Presence of an unresectable liver mass consistent with cholangiocarcinoma, for which treatment with gemcitabine plus cisplatin is intended.
A history of prior systemic treatment with gemcitabine or cisplatin. At least six months must have elapsed if gemcitabine or cisplatin was administered in an adjuvant treatment setting.
Known hypersensitivity to gemcitabine, azacytidine or cytosine arabinoside
Patient must have not received gemcitabine, oxaliplatin and/or paclitaxel chemotherapy agents
Patients who have received gemcitabine, oxaliplatin and/or paclitaxel are excluded from this study
No prior chemotherapy for locally advanced or metastatic pancreatic cancer\r\n* Patients are eligible if they received adjuvant treatment after surgical resection with single-agent gemcitabine or gemcitabine/capecitabine or 5-fluorouracil/leucovorin that was completed > 12 months before enrollment; similarly, adjuvant radiation +/- chemosensitization with 5-fluorouracil, capecitabine, or gemcitabine is allowed if completed > 12 months before enrollment
For Part D dose confirmation: All participants must have histological evidence of cholangiocarcinoma and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >1 line of prior systemic therapy for metastatic or resectable disease (that is, participants may have received adjuvant gemcitabine and then later gemcitabine/cisplatin for recurrent metastatic disease).
SAFETY RUN-IN: Patients who received prior therapy using carboplatin/gemcitabine within 12 months prior to enrollment or subjects whose tumor progressed while on treatment with carboplatin or cisplatin
RANDOMIZED PHASE II CLINICAL TRIAL: Patients who received prior therapy using carboplatin/gemcitabine within 12 months prior to their enrollment or subjects whose tumor progressed while on treatment with carboplatin or cisplatin
Radiosensitizing chemotherapy (taxol [paclitaxel], taxotere [docetaxel], cisplatin, gemcitabine [gemcitabine hydrochloride], 5-fluorouracil [fluorouracil]) given within one week of radiation treatment
Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.
Patients who have previously received gemcitabine plus oxaliplatin therapy
Prior therapy: No line limit but no more than 1 prior regimens in the platinum resistant setting; no prior treatment targeting the ATR/checkpoint kinase 1 (CHK1) pathway and no prior gemcitabine as single agent; hormonal therapies immunotherapy, and antiangiogenic therapies (as single agents) do not count as lines; poly (adenosine diphosphate [ADP]-ribose) polymerases (PARP)-inhibitors count as a line of therapy unless given in the maintenance setting; PARP-inhibitors given as maintenance after platinum therapy do not count as a line of therapy; prior carboplatin/gemcitabine is allowed provided that there was no disease progression within 12 months after completion of the carboplatin/gemcitabine regimen; subjects may begin protocol treatment at least 4 weeks or 5 half-lives, whichever is shorter, after their last dose of chemotherapy or hormonal therapy, assuming they are otherwise eligible
Must not have previously received chemotherapy or any investigational agent for the treatment of PDAC. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed for as long as last dose was administered > 6 months prior to randomization and no lingering toxicities are present.
Nab-paclitaxel with gemcitabine therapy is appropriate for the patient and recommended by the Investigator.
For male or female patients of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days after the final dose of nab-paclitaxel and gemcitabine or for 30 days for female patients and for 90 days for male patients, after the final napabucasin dose if nab-paclitaxel and gemcitabine were not administered.
A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed for as long as last dose was administered > 6 months prior to randomization.
Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for 4 weeks after the last dose of napabucasin or while undergoing treatment with nab-paclitaxel and gemcitabine and for 180 days after the last dose of nab-paclitaxel and gemcitabine.
Previous treatment with gemcitabine
In the opinion of the treating investigator, the patient must be a candidate to receive gemcitabine/cisplatin treatment
Patients must not be known to have hypersensitivity to cisplatin, gemcitabine, or celecoxib
Gemcitabine + nb-paclitaxel
50.4 Gy (1.8 Gy per fraction) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil
The patient has undergone at least one prior, but no more than 2 prior standard, therapies for pancreatic cancer.If the patient has had prior gemcitabine treatment, the last date of gemcitabine administration-should be > 3 months prior to screening for the study. All patients who have previously received gemcitabine should be discussed with the medical monitor during screening
Have received prior cisplatin and gemcitabine concomitantly within the last 6 months or are refractory to cisplatin and gemcitabine.
Have known hypersensitivity to platinum compounds or gemcitabine.
Prior treatment with gemcitabine and/or nab-paclitaxel in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
For phase 2, prior intravesical treatment with nab-rapamycin or gemcitabine is not allowed
Known severe hypersensitivity to gemcitabine
Histologically or cytologically confirmed grade 2 or 3 soft tissue sarcoma that is unresectable or metastatic that would be standardly treated with gemcitabine or gemcitabine and docetaxel; prior surgery for primary or metastatic disease after chemotherapy following a response is allowed
For patients selecting vinorelbine or gemcitabine as the TPC agent, patients may not receive yellow fever vaccine in the 28 days prior to randomization.
History of allergic reactions or hypersensitivity to the study drugs (hydroxychloroquine, gemcitabine, nab-paclitaxel, avelumab)
Completion of at least 3 months, but no more than 7 months of standard induction chemotherapy for LAPC, which should consist of either FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably with a washout period no longer than 8 weeks.
Prior treatment with cisplatin and/or gemcitabine
Have documented radiographic progression to or documented intolerance of first line systemic chemotherapy which included either gemcitabine or fluorouracil (5-FU) based regimen (including capecitabine)
Previous cytotoxic chemotherapy including cisplatin, carboplatin, oxaliplatin, etoposide, docetaxel, cabazitaxel, and gemcitabine is allowed, up to 3 prior regimens
Prior therapy with single-agent gemcitabine.
Prior history of hypersensitivity to gemcitabine.
Disease must be refractory to or intolerant of at least first-line chemotherapy which contains 5-fluorouracil or gemcitabine
Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug formulations.
To commence first-line standard nab-paclitaxel and gemcitabine chemotherapy, or gemcitabine alone, (per standard of care according to the approved prescribing schedule), within 7 to 14 days post enrolment, with OncoSil™ implantation to occur during the fourth (4th) week of the first chemotherapy cycle
Eligible for one of the chemotherapy options listed as TPC (Eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.
Patients must have received 1 line of prior systemic therapy for metastatic or resectable disease (i.e. patients may have received adjuvant gemcitabine and then later gemcitabine/cisplatin for recurrent metastatic disease)
Prior decitabine for the treatment of this cancer; patients with previous exposure to therapy with gemcitabine are allowed in the study
No more than one prior line of non-gemcitabine/nab-paclitaxel containing systemic therapy for metastatic/locally advanced pancreatic cancer
Known hypersensitivity to nintedanib, gemcitabine and nab-Paclitaxel, peanut or soy or any other trial drug, their excipients
Completion of at least 3 months, but no more than 12 months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably within 2-4 weeks but no longer than 8 weeks
History of allergy or hypersensitivity to albumin-bound paclitaxel, or gemcitabine
Have had disease progression, been refractory or intolerant to no more than 2 prior systemic regimens for locally advanced or metastatic pancreatic cancer. Participants who have received prior neoadjuvant therapy and who now have metastatic disease must have received 1 of the following for their metastatic disease: FOLFIRINOX, nanoparticle albumin-bound paclitaxel/gemcitabine, TS-1 (tegafur gimeracil oteracil potassium), irinotecan liposome injection/5-fluorouracil (5FU)/Leucovorin or single-agent gemcitabine prior to enrolment in this study.
The patient must be eligible for standard of care treatment with gemcitabine +nab-paclitaxel.
Patients who have been off of FOLFIRINOX or gemcitabine/abraxane therapy for more than 49 days prior to treatment on study
Patients who have had more than one line of chemotherapy for LAPC (other than the 4-8 cycles of FOLFIRINOX or gemcitabine/abraxane based chemotherapy); patients will be allowed to switch between FOLFIRINOX and gemcitabine/abraxane due to intolerance, but cannot have switched chemotherapy regimens due to radiographic or clinical disease progression
Patients who have only received single agent gemcitabine chemotherapy; abraxane component may be reduced or modified but must be included for a minimum of two cycles
Prior adjuvant chemotherapy with gemcitabine and/or docetaxel/paclitaxel is allowed
Patients with a known hypersensitivity to gemcitabine (Arm B only)
Patients previously treated with gemcitabine or Abraxane
Arms 1E: previously treated with and progressed on gemcitabine-containing therapy
Known hypersensitivity or infusion reaction to cisplatin and gemcitabine
Patients with known hypersensitivity to gemcitabine or docetaxel
Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses)
Patients who have received the combination of gemcitabine and docetaxel in the metastatic setting are excluded
Allocated to receive Gemcitabine + nab-Paclitaxel as first line treatment.
Use of concurrent gemcitabine-based chemotherapy during radiotherapy
Patient must have not received gemcitabine, oxaliplatin and/or paclitaxel chemotherapy agents
Patients who have received gemcitabine, oxaliplatin and/or paclitaxel are excluded from this study
Arm C eligible for treatment with one of the following standard, every 3 week, platinum-based salvage regimens (with or without monoclonal antibody as appropriate for the disease):\r\n* Ifosfamide/carboplatin/etoposide (ICE) or rituximab/ifosfamide/carboplatin/etoposide (RICE);\r\n* Cisplatin, cytarabine (cytosine arabinoside), dexamethasone (DHAP) or rituximab, cisplatin, cytosine arabinoside, dexamethasone (RDHAP);\r\n* Gemcitabine hydrochloride (gemcitabine), dexamethasone, cisplatin (GDP) or rituximab, gemcitabine, dexamethasone, cisplatin (RGDP);\r\n* Gemcitabine and oxaliplatin (GemOx) or rituximab, gemcitabine and oxaliplatin (RGemOx);\r\n* Oxaliplatin, cytosine arabinoside, dexamethasone (OAD) or rituximab, oxaliplatin, cytosine arabinoside, dexamethasone (ROAD)
Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or 5-FU or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
History of allergy or hypersensitivity to gemcitabine (or other drug excipients in TAR-200) or drugs chemically-related to gemcitabine.
Cohort 2 (MTD) only: patient willing to undergo muscle biopsies at baseline and after 28 to 35 days of disulfiram/gemcitabine or gemcitabine/placebo therapy as required by the protocol
Prior exposure to gemcitabine
Allergy/sensitivity to any study drug (gemcitabine, cisplatin, enzalutamide), or drugs chemically related to study drug, or excipients
PHASE II: Patients must NOT have received gemcitabine or nab-paclitaxel in a metastatic setting
Have not been treated with gemcitabine in the metastatic setting
Prior treatment with gemcitabine alone or 5-fluorouracil with radiation as an adjuvant therapy will be allowed; patient should not have received gemcitabine within 6 months of starting the study treatment; 5-flourouracil or radiation treatment should be received more than 4 weeks prior to receiving the study drug
Patients may have received prior chemotherapy for advanced disease as long as it did not include gemcitabine; if patients received prior adjuvant therapy including gemcitabine, patients must be > 6 months from the last dose of gemcitabine; patients must have recovered from side effects of prior therapy to grade =< 1 as measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0
Patients must not be known to have hypersensitivity to cisplatin, gemcitabine (gemcitabine hydrochloride), doxorubicin (doxorubicin hydrochloride), vinblastine (vinblastine sulfate), methotrexate or filgrastim/pegfilgrastim
Not a candidate for treatment with at least 1 of the treatments of protocol-specific physician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)
Patient who have had previous treatment with pazopanib or with weekly gemcitabine for recurrent or persistent disease
Has a history of severe hypersensitivity reaction (e.g. generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to pembrolizumab, gemcitabine, carboplatin, or cisplatin or their analogs and/or to any of their excipients.
Disease progression during or within 6 months after treatment with one line of 5-Fluorouracil (5-FU)- or gemcitabine-based chemotherapy in the metastatic setting
Patients who previously received gemcitabine for the treatment of recurrent disease
Have received Gemcitabine for palliative treatment or progressed while receiving it or is within 3 months of completion in the adjuvant setting.
Have a known history of HIV are excluded due to the possibility that Gemcitabine or NPC-1C(NEO-102) may worsen their condition and the likelihood that the underlying condition may obscure the attribution of adverse events with respect to Gemcitabine or NPC-1C(NEO-102).
Patients who have had prior therapy with docetaxel, gemcitabine hydrochloride, or doxorubicin hydrochloride at any time in their history
Participant for whom treatment with monotherapy chemotherapy such as gemcitabine or capecitabine is a reasonable choice.
Have a known hypersensitivity to investigator's choice of standard of care (gemcitabine or capecitabine).
For dose escalation phase (Phase Ib) 0 or 1 prior lines of chemotherapy for advanced pancreatic cancer. Prior gemcitabine is allowed, however prior nab-paclitaxel is not allowed.
No known hypersensitivity to gemcitabine or nab-paclitaxel
Patients enrolling onto Arm A (Gemcitabine and nab-Paclitaxel) or Arm B (mFOLFIRINOX) are allowed to have up to two prior lines of systemic therapy, with adjuvant therapy counted as one line of therapy as long as disease recurrence occurred > 6 months of last dose of therapy. Prior systemic therapy in the metastatic setting is allowed for as long as the therapy contained BBI608 in combination with either Gemcitabine and nab-Paclitaxel or mFOLFIRINOX. Toxicities related to prior therapy must have completely resolved (except for alopecia and anemia), or be deemed irreversible.
Patients who received Gemcitabine-based therapy in an adjuvant setting will be allowed to be enrolled on Arm A of the trial (Gemcitabine with nab-Paclitaxel) as long as their last Gemcitabine administration was at least 6 months prior to the first dose of BBI608.
Patients enrolling onto Arm A (Gemcitabine with nab-Paclitaxel) are allowed to have prior mFOLFIRINOX in combination with BBI608 in the metastatic setting.
Patients enrolling onto Arm B (mFOLFIRINOX) are allowed to have prior Gemcitabine with nab-Paclitaxel in combination with BBI608 in the metastatic setting.
For patients enrolling onto Arm A (Gemcitabine with nab-Paclitaxel) a. Known hypersensitivity to Gemcitabine or taxanes. i. Patients with history of Gemcitabine toxicity in the adjuvant setting requiring more than 1 dose level reduction are excluded. b. Significant cardiac disease, including the following: unstable angina, New York Heart Association class III-IV congestive heart failure, myocardial infarction within six months prior to study enrollment. c. History of hemolytic-uremic syndrome. d. History of posterior reversible encephalopathy syndrome. e. Known infection with Human Immunodeficiency Virus (HIV), and/or active infection with hepatitis B, or hepatitis C. f. History of active Peripheral Artery Disease (treated peripheral artery disease that is stable for at least 6 months is allowed).
Patients must not have a history of allergy or hypersensitivity to methotrexate, vinblastine, doxorubicin (doxorubicin hydrochloride), cisplatin, gemcitabine (gemcitabine hydrochloride), carboplatin or filgrastim or pegfilgrastim
For Part B (abemaciclib + gemcitabine): Any subtype. The participant must have received at least one but not more than three prior therapies for advanced/metastatic NSCLC.
Urothelial cancer arising in the bladder, renal pelvis, ureter or urethra that has progressed during or following at least 1 and up to 5 prior systemic treatments for unresectable locally advanced or metastatic disease (includes anti-PD-L1,anti-PD-1, but excludes other experimental therapies). Patients must have received at least one platinum-containing regimen (e.g., gemcitabine/cisplatin [GC], dose-dense methotrexate/vinblastine/doxorubicin/cisplatin [DDMVAC], or carboplatinum/gemcitabine). No more than 5 prior systemic regimens allowed.
History of needing to permanently discontinue prior gemcitabine/ cisplatin regimen for reasons other than progression (i.e. toxicity)
For stratum B patients must have received prior anthracycline-based therapy (or have a contraindication to receiving this treatment) and must not have received prior gemcitabine (gemcitabine hydrochloride)
Patients who have received prior non-gemcitabine-based systemic chemotherapy for metastatic disease or those who are beyond 12 months of exposure to gemcitabine-based chemotherapy regimen are allowed
Patients may have received prior adjuvant chemotherapy with gemcitabine with or without cisplatin, as long as 6 months have elapsed since last treatment.
Must have progressed on, been intolerant to, or refused gemcitabine-based therapy
Prior systemic chemotherapy allowed; it is anticipated and suggested that most patients enrolled on study will have received a minimum of approximately 2 months of systemic therapy according to routine institutional practices; the patient must also be felt by the treating medical oncologist and radiation oncologist to be a candidate for treatment with gemcitabine/nab-paclitaxel chemoradiotherapy
Serious underlying lung function abnormality due to the risk of fatal pneumonitis that was caused by the combination of Abraxane and gemcitabine
Cholangiocarcinoma subjects must have progressed following gemcitabine-based regimen.
Patients with advanced breast cancer who have received platinum therapy (e.g. carboplatin or cisplatin) and/or gemcitabine therapy for metastatic disease are excluded (platinum-based therapy and/or gemcitabine in the adjuvant or neoadjuvant setting is allowed)
Ovarian cancer patients who have received prior gemcitabine therapy are ineligible; (prior carboplatin therapy is allowed)
Any number of prior chemotherapy regimens; up to two prior chemotherapy regimens in the palliative setting will be allowed in the expansion cohort; prior gemcitabine-based regimens in the palliative setting are permitted if no evidence of progression on therapy or at least 6 months after discontinuation of gemcitabine-based treatment; prior gemcitabine in the adjuvant setting is permitted if last treatment was greater than 6 months prior to registration
Known or suspected allergy to gemcitabine or cisplatin
Any concern for hypersensitivity to pazopanib, gemcitabine or docetaxel
No prior treatment with bendamustine; prior therapy with gemcitabine is permitted
Patient is starting standard of care Gemcitabine treatment
Prior systemic therapy for advanced pancreas cancer with gemcitabine is prohibited; prior gemcitabine with radiotherapy for localized pancreas cancer is allowed provided disease is present outside of the radiated field; prior gemcitabine as adjuvant therapy to surgical resection is allowed provided 3 months or greater has elapsed between the last dose of gemcitabine and the detection of recurrent disease
History of hypersensitivity to gemcitabine
Patient has hypersensitivity to bortezomib, boron, mannitol, gemcitabine, or doxorubicin. Gemcitabine skin rash that be controlled by short course steroids is allowed.
Known hypersensitivity to nab-paclitaxel or to gemcitabine or to any of the excipients.
Prior treatment with gemcitabine
Eligible for treatment with nab-paclitaxel and gemcitabine on Days 1, 8, and 15 in 28-day cycles as standard therapy
No previous radiotherapy, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
Patients with contra-indication and/or history of severe hypersensitivity reactions to gemcitabine and/or nab-paclitaxel as mentioned in the locally approved label
Subject must have received no prior therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed. If a subject received gemcitabine in the adjuvant setting, tumor recurrence must have occurred at least 6 months after completing the last dose of gemcitabine.
Subject has a history of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients.
Therapy that does not include cisplatin, carboplatin, gemcitabine, and/or pemetrexed
Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
Received gemcitabine administered at a minimum dose of 800 mg/m2 per week in the first cycle of treatment
Progressed while receiving this gemcitabine regimen or within 3 months of completing gemcitabine
Completion of at least 3 months, but no more than 6 months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably within 2-4 weeks but no longer than 8 weeks
Prior first-line chemotherapy must have consisted of at least 4 cycles and no more than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin
Prior treatment with albumin-bound paclitaxel or gemcitabine
Patients with a diagnosis of advanced unresectable non-hematological malignancy that has no known standard of care or for which the use of gemcitabine plus cisplatin constitutes a reasonable option
Known hypersensitivity to gemcitabine
A single course of gemcitabine and/or docetaxel as adjuvant therapy that was completed at least 6 months prior to planned first dose
Prior treatment with MLN4924; however, prior treatment with docetaxel, paclitaxel,carboplatin, and gemcitabine is allowed
Any known contraindications to the use of a required comedication (gemcitabine or nab-paclitaxel).
History of prior significant toxicity from a same class of agents as GDC-0575 or gemcitabine requiring discontinuation of treatment
Histological confirmation of urothelial carcinoma and high risk residual disease after neoadjuvant chemotherapy (NAC) and cystectomy as defined by post-operative pathological pT4 or N1-3 disease, or progressive disease during NAC (NAC include methotrexate, vinblastin, doxorubicin and cisplatin [MVAC], dose dense MVAC, gemcitabine cisplatin, or gemcitabine carboplatin); minor histologic variants (< 50%) are acceptable if urothelial carcinoma is predominant variant
Previous exposure to gemcitabine instillations.
Previous treatment with irinotecan-based, nab-paclitaxel-based or gemcitabine-based resulting in disease progression
Patients with active non-hematologic cancer:\r\n* The patients have previously received a chemotherapy regimen including one or more of the following agents:\r\n** Nucleoside analogue, including gemcitabine and fluorouracil\r\n** Carboplatin or cisplatin\r\n** Anthracycline\r\n** Alkylating agent\r\n** Other chemotherapy agents with thrombocytopenia as known common toxicity
Minocycline Trial only: patients with a pathological or clinical diagnosis of pancreatic cancer and beginning or continuing FOLFIRINOX or gemcitabine-based chemotherapy
Patient with a history of severe hypersensitivity reaction to the planned study treatment including gemcitabine, paclitaxel, cisplatin, carboplatin, pemetrexed or any known excipients of these drugs
Prior treatment with gemcitabine-containing therapy for advanced disease (adjuvant therapy is allowed, provided not more than six cycles were administered and relapse occurred more than six months after the last drug administration), and/or:
Patients who have previously discontinued gemcitabine-containing regimens due to gemcitabine-related toxicity.
Prior treatment with protein-bound paclitaxel allowed if it has been six months since received or progressed on protein-bound paclitaxel and plan to continue to receive protein-bound paclitaxel with MinnelideTMcapsules
Patients may not have received paclitaxel, doxorubicin, or cyclophosphamide as anti-neoplastic therapy
History of grade 3-4 immediate hypersensitivity reaction to paclitaxel
paclitaxel
Patient must not have had prior treatment with paclitaxel or nab-paclitaxel
Patients for whom paclitaxel (or nab-paclitaxel) is being used in the curative setting, either adjuvant or neoadjuvant, and patients who would receive paclitaxel (or nab-paclitaxel) as first line therapy in a tumor type in which paclitaxel (or nab-paclitaxel) has a proven survival benefit for metastatic disease
Prior treatment with paclitaxel as part of definitive therapy regimen is acceptable, provided the patient is not intolerant of paclitaxel.
History of hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor® EL (polyoxyethylated castor oil). Patients who exhibit these hypersensitivities will be eligible to receive single agent DKN-01
History of allergic reactions attributed to compounds of similar chemical or biologic composition to mifepristone or paclitaxel/nab-paclitaxel; patients with a history of mild infusion reactions with paclitaxel who were able to continue to receive paclitaxel with corticosteroid premedication will be eligible to participate, as these cases were likely related to cremaphor and not paclitaxel
Has a known sensitivity to any component of carboplatin or paclitaxel or nab-paclitaxel.
Patients with advanced or metastatic solid tumors who have disease progression after treatment with available therapies and for whom nab-paclitaxel treatment is appropriate.
Participants who have a history of hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor® EL (polyoxyethylated castor oil) or to nab-paclitaxel and any of the excipients
Carboplatin or paclitaxel exposure within past 6 months.
Has a history of severe hypersensitivity reaction (e.g., generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to nab-paclitaxel or anti-PD1/PDL1 or human albumin
Known hypersensitivity to pirfenidone, carboplatin, pemetrexed or paclitaxel
Prior treatment with nab-paclitaxel (abraxane)
Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication; however, corticosteroid can be dropped after confirming of no asthma like reaction to paclitaxel after 3 doses
Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist; no other investigational or commercial therapeutic agents may be given concurrently with the paclitaxel
The planned treatment regimen must be concurrent chemoradiation with carboplatin-paclitaxel followed by surgery
Received prior treatment with nab-paclitaxel.
FOR PARTICIPANTS WHO WILL BE RECEIVING NAB-PACLITAXEL (ALL ARMS EXCEPT ARM B1 SINGLE AGENT LEAD-IN)
No treatment with paclitaxel or nab-paclitaxel within 4 months prior to initiation of study therapy
FOR PARTICIPANTS WHO WILL NOT RECEIVE NAB-PACLITAXEL (ARM B1 SINGLE AGENT LEAD-IN ONLY)
EXCLUSION CRITERIA SPECIFIC TO PATIENTS WHO WILL BE RECEIVING NAB-PACLITAXEL (ALL ARMS EXCEPT ARM B1 SINGLE AGENT LEAD-IN)
Participants with contra-indication and/or history of severe hypersensitivity reactions to nab-paclitaxel
Subjects must not have received paclitaxel or nab-paclitaxel within 4 months prior to initiation of study therapy
Participants with contra-indication and/or history of severe hypersensitivity reactions to nab-paclitaxel
Patients receiving any other investigational agents or are unable to be treated with doxorubicin, cyclophosphamide, and paclitaxel
Patients with a histologically confirmed or presumed diagnosis of gynecologic malignancy for whom chemotherapy with paclitaxel and carboplatin is planned
Consultation with a medical oncologist at enrolling site =< 56 days prior to registration, with determination that treatment with neoadjuvant chemoradiotherapy with weekly carboplatin and paclitaxel is considered acceptable
Planned chemotherapy with combination carboplatin and paclitaxel given intravenously
History of hypersensitivity to paclitaxel or carboplatin or their excipients
Patients with known history of hypersensitivity to paclitaxel that did not resolve with pre-medication
Prior treatment with paclitaxel in the metastatic setting is not allowed (patients who received neoadjuvant paclitaxel can be included)
Patients with a history of prior therapy with paclitaxel and/or carboplatin
Known hypersensitivity to any of the components of atezolizumab or nab-paclitaxel
Must be a candidate for treatment with either carboplatin plus paclitaxel or carboplatin plus PLD
Patients must be, after evaluation by the investigator, appropriate candidates for the administration of 5 to 6 cycles of standard platinum-based combination chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, or carboplatin and gemcitabine) following CRS with or without HIPEC
ARM A COHORT 1: Patients must not have prior nab-paclitaxel exposure
Subjects with any tumor type (except lung) for which carboplatin plus paclitaxel chemotherapy would be appropriate • Paclitaxel Arm:
Subjects with any tumor type (except lung) for which paclitaxel chemotherapy would be appropriate • Anastrozole Arm:
Carboplatin Plus Paclitaxel Arm:
Paclitaxel Arm:
Subjects who were previously treated with paclitaxel for locally advanced and/or metastatic disease and who in the opinion of the Investigator may benefit from the combination treatment of ARQ 092 and paclitaxel may be enrolled
For subjects enrolled in the Carboplatin Plus Paclitaxel Arm or Paclitaxel Arm, concurrent standard long-term anticancer hormonal therapy with drugs including but not limited to selective estrogen receptor modulators or Gonadotropin-releasing hormone (GnRH) analogs if started at least six months before the first dose of study treatment is allowed
History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride (HCL) or the components of doxil, paclitaxel, or carboplatin
Patient is suitable to receive standard chemotherapy with radiation during weeks 2-7 (e.g. cisplatin+ etoposide or carboplatin+paclitaxel)
History of hypersensitivity to paclitaxel
ELIGIBILITY CRITERIA FOR REGISTRATION: the subject and her physician must agree to 6 cycles (a total of up to 8 cycles will be allowed) of one of the standard of care regimens allowed on this protocol; these regimens (starting dosage) include:\r\n* < 70 years of age:\r\n** R1: IV paclitaxel 175 mg/m^2 and carboplatin area under the curve (AUC) 5-6 every 21 days\r\n** R2: IV docetaxel 75 mg/m^2 and carboplatin AUC 5-6 every 21 days\r\n** R3: IV paclitaxel 80 mg/m^2 day 1, 8, and 15 and carboplatin AUC 5-6 day 1 every 21 days\r\n* >= 70 years of age may (but not required to) choose one of the following alternative regimens:\r\n** R4: IV paclitaxel 135 mg/m^2 plus IV carboplatin AUC 5 plus optional filgrastim (G-CSF) every 21 days\r\n** R5: IV paclitaxel 60 mg/m^2 day 1, 8, and 15 plus IV carboplatin AUC 5 day 1 every 21 days (day 15 paclitaxel optional)\r\n** R6: IV paclitaxel 60 mg/m^2 plus IV carboplatin AUC 2 day 1, 8, and 15 every 21 days\r\n*** Use of granulocyte colony stimulating factor is permitted, but additional chemotherapy agents (e.g. gemcitabine) or biologic agents (e.g. bevacizumab) are not; dose modifications for patients >= age 70 are allowable as indicated above; patients >= age 70 for whom the physician deems carboplatin AUC 5 to be unsafe may be treated with AUC 4
Previous inability to tolerate any dose of paclitaxel (i.e., the subject required a paclitaxel dose reduction or discontinuation).
Subjects who have history of severe hypersensitive reaction to the active ingredient or any excipients of DHP107 or IV paclitaxel.
Known allergic reaction to talimogene laherparepvec, paclitaxel, aromatase inhibitors, tamoxifen, fulvestrant, or any of their components; an exception is made if the patient will not be receiving the offending agent/component (i.e. a patient who is allergic to paclitaxel but will be receiving endocrine therapy is eligible)
Known hypersensitivity to nab-paclitaxel or any of its excipients
Patients may not have received paclitaxel, doxorubicin, or cyclophosphamide as anti-neoplastic therapy
Patients who received and progressed on the combination of carboplatin/paclitaxel will not be eligible
Participants may have received prior treatment with weekly paclitaxel; however, participants who have had progression on or within 8 weeks of their last dose of weekly paclitaxel will not be eligible
For gynecologic cancer cohort only recurrent or progressive disease within 30 days of the last dose of weekly paclitaxel or nab-paclitaxel
Subject has previously been treated with nab-paclitaxel\t\r\n* NOTE: Subjects who have had previous treatment with nab-paclitaxel will NOT be excluded if given in the adjuvant or neoadjuvant setting\r\n* Only in the metastatic setting, will subjects previously treated with nab-paclitaxel be excluded from this trial; exceptions may be made for subjects who discontinued treatment with a previous nab-paclitaxel inhibitor for reasons other than progression and as long as it has been > 12 months since discontinuation of the previous nab-paclitaxel; this exception will require prior approval from the study principal investigator (PI) at University of Kansas Medical Center (KUMC)
Subject has a known hypersensitivity to any of the excipients of nab-paclitaxel or BYL719/alpelisib
Known hypersensitivity to any component of bevacizumab or to nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation)
Patients with recurrent disease may have received prior treatment with carboplatin/paclitaxel but must have had a treatment free interval of > 6 months
Participants with known hypersensitivity to carboplatin, paclitaxel, or formulations containing polyethoxylated castor oil (Cremophor).
History of allergy or hypersensitivity to nab-paclitaxel or carboplatin. 9. Currently enrolled in any other clinical protocol or investigational trial that involved administration of experimental therapy and/or therapeutic devices.
Any contraindication to the use of cisplatin, carboplatin, or paclitaxel chemotherapy
Suitable candidate for single agent nab-paclitaxel as assessed by the investigator.
Weekly paclitaxel for recurrent or persistent disease.
Non-pregnant and non-nursing. The effect of nab-paclitaxel and nivolumab on the fetus is unknown.
Prior nab-paclitaxel chemotherapy excluded.
Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic agents (biologic/ targeted) or extended therapy administered after surgical or non-surgical assessment; if patients were treated initially with paclitaxel for their primary disease, this can have been given weekly or every 3 weeks; the most recent therapy and any therapies subsequent to initial therapy, however, cannot have contained weekly paclitaxel; if the immediate prior (most recent therapy) is the initial therapy, it may not have been with weekly paclitaxel
Has known hypersensitivity to paclitaxel
Known allergy or hypersensitivity to paclitaxel or any components used in the paclitaxel preparation or other contraindication for taxane therapy
Must have completed concurrent chemoradiation with a standard chemotherapy regimen (either cisplatin/etoposide or carboplatin/paclitaxel) and a dose of radiation ranging from 59.4-66.6Gy
Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
Known hypersensitivity to any of the components of ipilimumab, bevacizumab, or nab-paclitaxel
Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
Prior treatment with nab-paclitaxel.
History of prior paclitaxel therapy
Deemed eligible to receive neoadjuvant chemotherapy with 12 cycles of weekly taxane therapy (paclitaxel 80 mg/m2 or abraxane 100 mg/m2 if there is a shortage of paclitaxel) followed by 4 cycles of adriamycin (60 mg/m2) and cyclophosphamide (600 mg/m2) given every 2 weeks with growth-factor support
Known hypersensitivity to doxorubicin, cyclophosphamide, paclitaxel, Cremophor or medications containing Cremophor (miconazole, docetaxel, Sandimmune, nelfinavir mesylate, propofol, diazepam injection, vitamin K injection, ixabepilone, Aci-Jel) or carboplatin
Known hypersensitivity to Cremophor EL. However, participants are eligible if they have had a prior paclitaxel reaction, but subsequently tolerated the drug at rechallenge.
Known hypersensitivity to protein bound paclitaxel
Patient must not have previously received nab-paclitaxel
No known prior hypersensitivity to carboplatin, paclitaxel, bevacizumab or hydroxychloroquine or any of their components
History of known allergy or contraindications to the use of pazopanib, paclitaxel, or carboplatin
CARBOPLATIN AND PACLITAXEL ARMS: absolute neutrophil count >= 1,500/mL
CARBOPLATIN AND PACLITAXEL ARMS: platelets >= 100,000/mL
CARBOPLATIN AND PACLITAXEL ARMS: patient with neuropathies of Common Toxicity Criteria (CTC) grade 1 or less
PACLITAXEL ARM: hypersensitivity to paclitaxel or any component of the formulation
History of hypersensitivity to nab-paclitaxel or paclitaxel
Weekly paclitaxel must be an acceptable treatment option
Currently or previously treated with conventional chemotherapy, or other agents for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib + nab-paclitaxel only)
Known hypersensitivity to nab-paclitaxel (Arm: idelalisib + nab-paclitaxel), their metabolites, or formulation excipients
Patients who have experienced a previous grade 3 or 4 anaphylactic reaction to paclitaxel
Cytotoxic chemotherapy, such as dacarbazine, temozolomide, carboplatin +/-paclitaxel.
Patients with prior therapy with paclitaxel or other taxanes.
Prior treatment with PM01183 or weekly paclitaxel or nanoalbumin-paclitaxel
Patients who have previously discontinued paclitaxel-based regimes due to drug related toxicity.
have not been treated with weekly paclitaxel after first-line treatment in which weekly paclitaxel plus a platinum is permitted
Prior anaphylactic or severe hypersensitivity reaction to paclitaxel or Cremophor-containing agent.
History of or suspected allergy to nab-paclitaxel, carboplatin and human albumin or any other platinum-based therapy.
Paclitaxel therapy is appropriate for the patient and is recommended by the Investigator.
Known hypersensitivity or history of severe intolerance or toxicity to study-assigned chemotherapy. Note: History of severe hypersensitivity reactions to docetaxel (polysorbate 80-based formulations) for participants to be treated with MLN4924 + docetaxel; history of hypersensitivity to carboplatin for participants to be treated with MLN4924 + carboplatin + paclitaxel; or history of severe hypersensitivity to paclitaxel (Cremophor-based formulations) for participants to be treated with MLN4924 + carboplatin + paclitaxel in Part B.
History of intolerance or hypersensitivity to paclitaxel and/or adverse events related to paclitaxel that resulted in paclitaxel being permanently discontinued
Subjects with a known history of allergy to paclitaxel. Subjects whose allergy was due to the IV solvent (such as Cremophor®) and not paclitaxel will be eligible for this study.
Prior therapy with weekly paclitaxel for recurrent disease (administration of weekly paclitaxel as part of an upfront treatment strategy is acceptable as long as the patient had not progressed while receiving weekly paclitaxel or recurred within 4 months of receiving weekly paclitaxel)
Patients with prior paclitaxel exposure are ineligible unless they are > 6 months from the conclusion of paclitaxel-based therapy
History of severe hypersensitivity reactions to docetaxel (polysorbate 80-based formulations) for patients to be enrolled in Arm 1 (MLN4924 + docetaxel), history of hypersensitivity to carboplatin for patients to be enrolled in Arm 2 (MLN4924 + paclitaxel + carboplatin), or history of severe hypersensitivity to paclitaxel (cremophor-based formulations) for patients to be enrolled in Arm 2
Received prior paclitaxel therapy or had clinically documented reason why not administered
Known history of dose-limiting hypersensitivity reactions to paclitaxel/Cremophor EL
A history of a severe hypersensitivity reaction to nab-paclitaxel
History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane
Prior therapy allowed but, no prior therapy with nab-paclitaxel, paclitaxel, temozolomide, dacarbazine or bevacizumab
Have completed neurotoxic chemotherapy, i.e. taxanes (paclitaxel, docetaxel) and platinum (carboplatin) at least 3 months prior to enrollment
Patients receiving the initial course of chemotherapy including \r\n* Paclitaxel 135 mg/M2 IV over 3 hours on day 1 and \r\n* Cisplatin 75 mg/M2 IP on day 2  OR  \r\n* Paclitaxel 80 mg/m2 IV days 1, 8 and 15 and \r\n* Carboplatin AUC 6 IP on day 1
Planned dose-dense chemotherapy with combination carboplatin and paclitaxel given intravenously
The patient’s previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) and considered the primary cause of the neuropathy by the medical team
Known hypersensitivity to paclitaxel, Cremophor EL, or iodinated contrast media
The patient’s previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) or platinum (cisplatin, oxaliplatin, or carboplatin) and considered the primary cause of the neuropathy by the medical team
Known severe hypersensitivity to paclitaxel
Subject appropriate for cytoreductive surgery and treatment with IV platinum and paclitaxel
Eligible for treatment with paclitaxel, doxorubicin and cyclophosphamide
Has a known history of hypersensitivity or allergy to pembrolizumab and any of its components and/or to any of the study chemotherapies (e.g., nab-paclitaxel, paclitaxel, gemcitabine, or carboplatin) and any of their components.
Known hypersensitivity to protein bound paclitaxel