Participants may not have current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
Patients may not have current signs and/or symptoms of bowel obstruction within 1 month prior to starting study drugs, except if it was a temporary incident (improved within < 24 hours [hr] with medical management)
Tumor is causing symptomatic bowel obstruction (patients who have had a temporary diverting ostomy are eligible)
Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
Patients must not have evidence or history of veno-occlusive disease or sinusoidal obstruction syndrome
Symptomatic bowel obstruction within 6 months prior to screening visit
Serum total bilirubin within normal range for the institution (biliary drainage is allowed for biliary obstruction) (within 14 days of treatment initiation)
Hospitalization for bowel obstruction within 3 months prior to enrollment
No condition that could affect the absorption of study drug, including any of the following:\r\n* Malabsorption syndrome\r\n* Disease significantly affecting gastrointestinal function\r\n* Bowel obstruction or sub-obstruction
History of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.
Patients with clinical symptoms or signs of gastrointestinal obstruction
Subject has a variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.).
a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug
Any gastrointestinal condition causing malabsorption or obstruction (e.g. celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
Ongoing bowel perforation or presence of bowel fistula or abscess or history of small or large bowel obstruction within 3 months of registration, including subjects with palliative gastric drainage catheters. Subjects with palliative diverting ileostomy or colostomy are allowed if they have been symptom-free for more than 3 months.
Malignant bowel obstruction
The presence of or imminent occurrence of airway obstruction, unless tracheostomy in place.
Active bowel obstruction, ileus, or active or remote pancreatitis
History of bowel obstruction within 28 days from proposed start of treatment
Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy
Morbidities or concurrent major illness (for example, bowel obstruction or a second active malignancy) that, in the opinion of the treating healthcare provider, would make participation in the trial problematic
History of bowel obstruction within 1 month prior to starting study drugs
No recent (=< 3 months) of partial or complete bowel obstruction unless surgically corrected
Evidence of complete or partial bowel obstruction
Symptomatic evidence of gastric outlet obstruction
Severe constipation or condition where exacerbation of constipation is not advisable (e.g. small bowel obstruction history)
Patients with biliary obstruction or biliary stent are excluded
Subjects with bowel obstruction
Hydronephrosis or biliary obstruction
Patients who have had a stent placed for biliary obstruction can be included in the study provided serum bilirubin at time of enrollment is within protocol limits
Any signs or symptoms of bowel obstruction within 28 days prior to study entry
For individual baskets: Appendiceal adenocarcinoma: Must not have clinically symptomatic malignant bowel obstruction; Cutaneous squamous cell carcinoma: none; Small bowel adenocarcinoma: must not have clinically symptomatic malignant small bowel obstruction
Patients with known urinary outflow obstruction
Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)
Patients must have a serum creatinine less than or equal to 2.0 mg/dL and total bilirubin less than or equal to 2.0 mg/dL in the absence of biliary obstruction; if the patient has biliary obstruction, biliary decompression will be required; either endoscopic placement of a biliary stent or percutaneous transhepatic drainage is acceptable; once biliary drainage has been established, institution of protocol therapy may proceed when the total bilirubin falls to 4.0 mg/dL or lower)
Clearance of 99mTc mercaptoacetyltriglycine (MAG3) within 1.5 x ULN and no evidence of obstruction on the scan
Unresolved partial or complete small or large bowel obstruction.
Patients with active ? grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
Subject with extensive pelvic mass at risk of fistulization, or history of bowel obstruction within 3 months prior to the proposed first dose of study treatment
History of bowel obstruction within 1 month prior to starting study drugs
Clinical evidence of bowel obstruction at the time of study entry
Have a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection or chronic diarrhea.
Patients who have a history of a small or large bowel obstruction within 2 weeks of screening or who have and active partial small bowel obstruction or percutaneous endoscopic gastrostomy (PEG)-tube
Small bowel obstruction
Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
Signs or symptoms of gastrointestinal obstruction
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nCurrent signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 28 days before study enrollment
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nCurrent signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 28 days before study enrollment
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
Tumor-induced symptomatic bowel obstruction
Relief of biliary obstruction if present (percutaneous transhepatic cholangiography [PTC] tube or endobiliary stent)
Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
Patients with a history of gallbladder problems or gall stones or biliary obstruction, unless patient had cholecystectomy
Total bilirubin =< 3, (with relief of biliary obstruction if present [percutaneous transhepatic cholangiography (PTC) tube or endobiliary stent])
Patients with tumor-caused symptomatic bowel obstruction
Symptomatic evidence of gastric outlet obstruction
The presence of complete or partial bowel obstruction based upon clinical assessment
Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy
Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum
No evidence of biliary duct obstruction, unless obstruction is controlled by local treatment or, in whom the biliary tree can be decompressed by endoscopic or percutaneous stenting with subsequent reduction in bilirubin to below 1.5 x upper level of normal (ULN)
Total bilirubin < 2.0 mg/dl with relief of biliary obstruction if present (percutaneous transhepatic cholangiography [PTC] tube or endobiliary stent)
Gastrointestinal ailments that may alter the absorption of oral medications (i.e. bowel obstruction, short-gut syndrome)
Primary hepatic dysfunction including known cirrhosis or active hepatitis. Patients with biliary obstruction must be stented prior to initiating treatment.
Patients with active ? grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
Documented malignant biliary obstruction requiring endoscopic retrograde cholangiopancreatography (ERCP) guided stenting; documentation of malignancy will be made before the scheduled procedure and rapid pathology readings will not be used as a documentation of malignancy; documentation of malignancy may be in the form of;\r\n* Histology (bile duct biopsy)\r\n* Liver or pancreas fine needle aspiration (FNA), biliary\r\n* Brush cytology\r\n* Malignant ascites\r\n* Peritoneal biopsy\r\n* Cross sectional imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) and abnormal liver function tests (findings compatible with obstruction)
Patients with evidence of high-grade symptomatic duodenal obstruction
Has inability to take oral medications and/or has clinical or radiological diagnosis of bowel obstruction.
Patients with active ? Grade 3 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
Unresolved partial or complete small or large bowel obstruction.
For patients with a recently placed biliary stent, patients should have consistent results within a hepatic group from two laboratory readings within 3 days apart, taken at least 10 days following biliary stent placement; for patients with a biliary stent placed over 2 months ago, no obstruction or blockage can have occurred within the last 2 months
Complete or partial intestinal obstruction at the time of study enrollment
Any signs, symptoms, and/or radiographic evidence of a complete or partial bowel obstruction
Clinically significant gastrointestinal (GI) disorders, including history of small bowel obstruction unless the obstruction was a surgically treated remote episode
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome); unable or unwilling to swallow tablets BID
Sinusoidal obstruction syndrome (SOS) if present, must be stable or improving clinically
Imaging evidence of common bile duct obstruction
Total bilirubin =< 3.0 x the upper limits of normal (ULN) (biliary stenting or percutaneous biliary drainage are allowed for cancer related biliary obstruction)
Cancer antigen 19-9 (CA19-9); NOTE: in the event that a stent has been placed and biliary obstruction has been relieved, the CA19-9 should be drawn post stent placement
Patients with ureteral obstruction (i.e., hydronephrosis identified on CT imaging) must undergo stent or nephrostomy tube placement prior to study entry
History of gastrointestinal disease causing malabsorption or obstruction such as, but not limited to Crohn’s disease, celiac sprue, tropical sprue, bacterial overgrowth/blind loop syndrome, gastric bypass surgery, strictures, adhesions, achalasia, bowel obstruction, or extensive small bowel resection
Evidence of complete or partial bowel obstruction or other unable to take oral medications
Evidence of complete or partial bowel obstruction or other unable to take oral medications
The participant has bowel obstruction or history of chronic diarrhea that is considered clinically significant.
History of bowel obstruction or malabsorption syndromes (within the last 3 months) which might limit the absorption of the study drug
Active bowel obstruction, or hospitalization for bowel obstruction within 2 months prior to screening
Patients must be able to tolerate oral medication and not have evidence of active bowel obstruction\r\n* Note: patients can have a history of prior bowel obstruction, provided the patient is not having symptoms of bowel obstruction at the time of enrolment and the bowel obstruction is not anticipated to recur during the participation in the study
allow bilirubin up to 2.5 times ULN if elevation is not associated with other signs of liver toxicity or can be explained by mechanical obstruction - requires clinical research physician approval.
Patients with biliary or gastro-duodenal obstruction must have drainage or surgical bypass prior to starting chemotherapy.
Appendiceal adenocarcinoma basket\r\n* Complete or partial bowel obstruction
malignant biliary obstruction unless the bile flow to the gastrointestinal tract is maintained by a fully operational biliary stent
have a serious illness or medical condition including, but not limited to, the following: active or uncontrolled clinically serious infection; inadequate biliary drainage with evidence of unresolved biliary obstruction
Has symptoms of bowel obstruction in the past 3 months
Have an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator.
Subjects with bladder inflammation and urinary outflow obstruction.
Clinically significant signs and/or symptoms of bowel obstruction within 3 months prior to starting treatment
The following are additional exclusion criteria for patients enrolling post safety run in:\r\n* Any clinical or radiographic evidence of a partial or complete bowel obstruction (small or large bowel) currently or within the past 6 months\r\n* No current dependency on total parental nutrition (TPN) or within the past 30 days
Has other serious illness or medical condition, such as active infection, unresolved bowel obstruction, psychiatric disorders, or cerebrovascular accident within 1 year of study start
Subjects who have a history or current evidence of malignant biliary obstruction requiring biliary stent.
Participants may not have current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
Total bilirubin less than or equal to 2.0 mg/dL in the absence of biliary obstruction; if the patient has biliary obstruction, biliary decompression will be required; either endoscopic placement of biliary stent (7 French or greater) or percutaneous transhepatic drainage are acceptable; once biliary drainage has been established, institution of gemcitabine therapy may proceed when the total bilirubin falls to =< 4.0 mg/dL; patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting chemoradiation
History of bowel obstruction, refractory ascites, or bowel perforation due to advanced disease within the past 3 months from start of study treatment
Patients with active biliary obstruction; NOTE: patients for which a shunt has been in place for at least 10 days prior to the first dose of dabrafenib are allowed
No evidence of biliary duct obstruction, unless obstruction is controlled by local treatment or, in whom the biliary tree can be decompressed by endoscopic or percutaneous stenting with subsequent reduction in bilirubin to below 1.5 x upper level of normal (ULN)
Total bilirubin =< 2 mg/dl; patients with biliary obstruction can join if bilirubin corrects to required limit after adequate biliary drainage
Presence of bowel fistula
Patients who currently have bile duct obstruction or cholelithiasis
Patient has any signs of intestinal obstruction
Anticipation of immediate need for a major surgical procedure (e.g., impending bowel obstruction, gastrointestinal perforation) or radiation therapy during the trial
Hospitalization for bowel obstruction within 3 months prior to enrollment.
Biliary obstruction, biliary stent, or prior biliary surgery including sphincterotomy but excluding cholecystectomy
Subjects with evidence of recto?sigmoid involvement by pelvic examination or bowel involvement on\r\ncomputed tomography (CT) scan or clinical symptoms of bowel obstruction
History of small or large bowel obstruction within 3 months of registration, including subjects with palliative gastric drainage catheters; subjects with palliative diverting ileostomy or colostomy are allowed if they have been symptom free for more than 3 months
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
Patients that require urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression
No medical condition that could interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction)
Patients who have required any treatment (medical or surgical) for bowel obstruction prior to diagnosis of bladder cancer or who have required surgical treatment for bowel obstruction after the cystectomy
Participant with veno-occlusive disease (ie, sinusoidal obstruction syndrome)
Have a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection or chronic diarrhea
Have other serious illness or medical condition, such as active infection, unresolved bowel obstruction, psychiatric disorders, or cerebrovascular accident within 1 year of study start
Biliary obstruction or presence of a percutaneous biliary drain. Note: Subjects with endobiliary stents may participate as long the enrollment criterion relating to serum bilirubin concentration is met.
Subject has confirmed cholestatic hyperbilirubenemia due to bile duct obstruction. Subjects who have liver dysfunction due to metastasis alone are excluded.
Patients who are unable to take oral medications and/or who have a clinical or radiological diagnosis of bowel obstruction are ineligible
Recent history (? 3 months) or ongoing partial or complete bowel obstruction unless due to disease under study and corrected with surgery.
Bulky disease (any single mass >10 cm). ->Grade 2 nausea or vomiting, and/or signs of intestinal obstruction.
Mechanical obstruction that would prevent adequate oral nutritional intake.
Patients with partial or complete bowel obstruction due to abdominal carcinomatosis
Patients with biliary obstruction for which a stent has been placed are eligible, provided the stent has been in place for at least 10 days prior to the first dose of belinostat and the liver function has stabilized; two measurements at least 2 days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function; there should be no evidence of biliary sepsis
Patient shows evidence of severe hepatic veno-occlusive disease (VOD) or sinusoidal obstruction.
Current bowel obstruction
At a higher than average risk, in the Investigator's opinion, of bowel perforation (e.g., symptoms of partial or complete bowel obstruction, recent (within 6 months) history of fistula or bowel perforation, requirement for total parenteral nutrition and continuous hydration)
Participants with biliary obstruction for which a stent had been placed are eligible provided that the stent has been in place for more than 14 days before the first dose of alisertib and liver function has stabilized.
Subjects with biliary obstruction for whom a biliary drain or stent has been placed are eligible, provided that the drain or stent has been in place for at least 10 days prior to the first dose of Tivantinib, and the subject's liver function has stabilized as defined by 2 measurements at least 5 days apart that put the subject in the same hepatic impairment group
Recent (? 3 months) history of partial or complete bowel obstruction.
Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention
Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator.
Unresolved diarrhea and bowel obstruction
No acute gastrointestinal conditions, such as: obstruction, fecal impaction, obstipation, acute surgical abdomen, ongoing need for manual maneuvers to induce bowel movements (such as digital evacuation)
Have clinical evidence of current or impending bowel obstruction
Patient has a history of irritable bowel syndrome, signs of active gastrointestinal (GI) bleeding, acute surgical abdomen, bowel stents, indwelling peritoneal catheter, mechanical GI obstruction, fecal impaction, or fecal ostomy
Clinical asthma (variable and recurrent symptoms of airflow obstruction and airway hyper-responsiveness)
Clinical evidence of bowel obstruction at the time of study enrollment
Evidence of any alimentary tract obstruction or other condition preventing oral alimentation
Bowel obstruction
Risk for gastric aspiration (ie; ileus, esophageal or bowel obstruction, active vomiting)
Intestinal obstruction
Has intestinal obstruction
Known upper gastrointestinal (UGI) tract obstruction precluding ERC.
Prior endoscopic retrograde cholangiopancreatography (ERCP) or PTBD for hilar obstruction.
Inability to increase food intake (e.g., esophageal obstruction, intractable nausea and vomiting)
History of gastrointestinal or genitourinary obstruction or porphyria
Patients with complete or partial bowel obstruction as determined by the palliative care physician
History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction within 6 months prior to Day 1 of Cycle 1
No cross sectional imaging findings indicative of multi-segmental (> 1 site) small bowel obstruction, or small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity
Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
Evidence of complete or partial bowel obstruction
Patients with bile duct obstruction
Minocycline trial only: patients who currently have bile duct obstruction or cholelithiasis
Patients with a history of or current bowel obstruction
Inoperable malignant neoplasm causing biliary obstruction or stricture that requires a fully covered metal stent
Current anatomy upstream of intended stent placement compromising the flow of bile from the liver such that stent placement may not alleviate the biliary obstruction symptoms
Jaundice secondary to a cause other than biliary duct obstruction
Opiate-induced uncontrolled constipation or bowel obstruction
Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
History of gastrointestinal or genitourinary obstruction or porphyria
Diagnosis of/problems with chronic diarrhea or history of bowel obstruction or esophageal stricture
Patient suffering from ongoing vomiting from any organic etiology (including patients with history of gastric outlet obstruction or intestinal obstruction due to adhesions or volvulus, patients with a symptomatic central nervous system(CNS) tumor causing nausea and/or vomiting) or patient with hydrocephalus.
Patients with biliary obstruction for which a stent has been placed are eligible, provided the shunt has been in place for at least 10 days prior to the first dose of romidepsin and the liver function has stabilized; two measurements at least 2 days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function; there should be no evidence of biliary sepsis
Previously diagnosed high-grade tracheal obstruction
Unresolved bowel obstruction
No evidence of biliary duct obstruction unless obstruction controlled by local treatment or, the biliary tree can be decompressed by endoscopic or percutaneous stenting with subsequent reduction in bilirubin to ?1.5×ULN
Biliary obstruction for whom a biliary drain or stent has been placed are eligible, provided that the drain or stent have been in place for at least 10 days prior to the first dose of crizotinib, and the liver function has stabilized as defined by 2 measurements at least 5 days apart that put the patient in the same hepatic dysfunction stratum as defined in Section 3.
Patient must have malignant bowel obstruction (MBO) as evidenced by all of the following:\r\n* Clinical evidence of a small bowel obstruction (via history, physical, and radiographic examination)\r\n* Bowel obstruction below (distal to) ligament of Treitz\r\n* Intra-abdominal primary cancer with incurable disease
Patients must have malignant bowel obstruction due to an intra-abdominal primary cancer (i.e. gastrointestinal [GI], pancreas, ovarian, uterine, cervical, kidney, bladder, prostate, gastrointestinal stromal tumor [GIST] [all sites], and sarcoma); patients may still have primary tumor as long as it is not a primary large bowel obstruction from colorectal cancer
Known bladder outlet obstruction.
Suspicion or known history of gastrointestinal obstruction