INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Histologically confirmed metastatic adenocarcinoma of the pancreas
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: Histologically confirmed metastatic adenocarcinoma of the pancreas
Patient has definitive histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. Patients with islet cell or neuroendocrine neoplasms are excluded.
Patients must have histologically or cytologically documented advanced or metastatic adenocarcinoma of the pancreas
Participants with biopsy-proven adenocarcinoma of the pancreas that is determined to be potentially or borderline resectable by National Comprehensive Cancer Network (NCCN) criteria
Histologically or cytologically proven adenocarcinoma of the pancreas
Histologically or cytopathologically confirmed adenocarcinoma of the pancreas
Histologic or cytologic diagnosis of adenocarcinoma of the pancreas
Histologically confirmed adenocarcinoma of the pancreas or ampulla of Vater; at least the majority of the histopathologic specimen must be identified as adenocarcinoma as opposed to another histologic subtype; in patients with a diagnosis of recurrent disease (based on radiographic progression and/or rising CA19-9 levels) and a history of a biopsy-proven adenocarcinoma of the pancreas or the ampulla of Vater, repeat biopsy of the recurrence site is not required for participation of the trial
Diagnosis of ductal adenocarcinoma of the pancreas (PDAC).
Patients with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
Histologically or cytologically confirmed pancreas adenocarcinoma receiving initial chemotherapy for metastatic disease and without evidence of disease progression on treatment
For Part II (Arm C): Patients can have either locally advanced or metastatic pancreas adenocarcinoma; up to two prior treatment regimens are permissible (excluding a prior PARP inhibitor) for either localized or metastatic pancreas adenocarcinoma; prior combined chemotherapy and radiotherapy is permissible provided the patient has measurable disease outside the radiation port; prior therapy must have been completed at least 3 weeks prior to starting study therapy
Histologically-proven invasive adenocarcinoma of the pancreas
Primary tumor may be located anywhere in the pancreas
Have a newly diagnosed, biopsy-proven adenocarcinoma of the head, neck and uncinate of the pancreas, and is a candidate for a pancreaticoduodenectomy; if the biopsy is not sufficient for diagnosis, the patient can be considered to meet eligibility if the study team agrees that clinically the patient’s tumor is suspected to be adenocarcinoma
Subjects must have histologically or cytologically confirmed adenocarcinoma of the pancreas
Cytologic or histologic proof of adenocarcinoma of the pancreas; patients can have tumor which is locally advanced or borderline resectable; unequivocal metastases and islet cell tumors are not eligible
Adenocarcinoma of the pancreas
Histologically or cytologically proven adenocarcinoma of the pancreas (within the last 90 days)
Pathologically confirmed adenocarcinoma of the pancreas
Histologically and/or cytologically confirmed adenocarcinoma of the pancreas, clinical stage T1-4, N0-1, M0
Patients must have pathologically confirmed adenocarcinoma of the pancreas
Subjects with biopsy-proven potentially resectable or borderline adenocarcinoma of the pancreas as determined by National Comprehensive Cancer Network (NCCN) criteria
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Patients who have had prior chemotherapy or radiotherapy for the treatment of pancreas cancer
Histologically proven adenocarcinoma of the pancreas
Histologic or cytological diagnosis of recurrent or metastatic pancreas adenocarcinoma (PCA) who present for first line chemotherapy treatment
Histologically or cytologically proven adenocarcinoma of the pancreas that has been resected with a close (< 2.5mm) or positive margin based on surgical and pathological findings
Cancer of pancreas, colon or rectum
Cohort 2 (MTD) only: metastatic adenocarcinoma of the pancreas; prior systemic treatment for metastatic disease is allowed
COHORT II (MTD): metastatic adenocarcinoma of the pancreas and tumor amenable to biopsies; prior systemic treatment for metastatic disease is allowed
Have histologically proven adenocarcinoma of the pancreas; patients with mixed histology will be excluded
PHASE II: Patients must have histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas with no prior systemic therapy for metastatic disease
Histologically or cytologically proven diagnosis of adenocarcinoma of the pancreas prior to registration
Subject has a definitive histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas. Subjects with islet cell neoplasms are excluded.
Metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are not eligible.
Patients must have histologic or cytologic evidence of adenocarcinoma of the pancreas, such as a core tissue biopsy or a surgical resection specimen.
adenocarcinoma of the pancreas,
Histologically confirmed adenocarcinoma of the pancreas that has been documented to be resectable by standardized radiographic criteria by a pancreatic surgeon
Histological diagnosis of adenocarcinoma of the pancreas
Histological documentation of primary adenocarcinoma of the pancreas
Patients must have histologically or cytologically confirmed carcinoma of the pancreas; most cases will be adenocarcinoma; cases with “undifferentiated” or “poorly differentiated” carcinoma will also be eligible
Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is considered unresectable or borderline resectable based on institutional standardized criteria of unresectability or medical inoperability; patients with and without regional adenopathy are eligible
Have histologically- or cytologically-proven adenocarcinoma of the pancreas; patients with mixed histology will be excluded
Previously untreated, apparently resectable, adenocarcinoma of the pancreas at registration
Pathologically confirmed adenocarcinoma of the pancreas; patients have resectable borderline resectable disease, or unresectable disease with no evidence of distant metastases or peritoneal disease; the maximum dimension of the tumor must be =< 10 cm
Histologically or cytopathologically confirmed adenocarcinoma of the pancreas
A histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology.
Histologic or cytologic diagnosis of adenocarcinoma of the pancreas.
Resectable primary tumor of the head, body or tail of the pancreas defined as a visible mass in the pancreas and:
Cytologic or histologic proof of adenocarcinoma of the pancreas is required prior to treatment; patients with Islet cell tumors are not eligible
Prior systemic therapy for pancreas cancer
Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas; patients who have not undergone biopsy but have highly suspected adenocarcinoma of the pancreas with borderline resectable features on imaging study may also be eligible for study and undergo the pretreatment biopsy as per protocol; the biopsy must confirm adenocarcinoma of the pancreas to continue on study; biopsy is required within 14 days of starting therapy
Histologically or cytologically proven diagnosis of metastatic ductal adenocarcinoma of the pancreas.
Histologically or cytologically confirmed adenocarcinoma of the pancreas.
Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
A histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology.
Histologically confirmed metastatic or advanced inoperable adenocarcinoma of the pancreas with immunohistochemistry (IHC) evidence of guanylyl cyclase C (GCC) expression indicated by an H-score of 10 or greater.
Treatment with 1 or more prior chemotherapies for advanced or metastatic adenocarcinoma of the pancreas.
Histologically or cytologically confirmed adenocarcinoma of the pancreas.
Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
The presence of a mass in the pancreas, OR
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Patient has histologically or cytologically confirmed localized adenocarcinoma of the pancreas including tumors in the pancreatic head, uncinate process, neck, body and tail that are potentially resectable by pancreatico-duodenectomy (Kausch-Whipple procedure); patients with islet cell or other neuroendocrine neoplasms are excluded
Patient has histologically or cytologically confirmed borderline resectable adenocarcinoma of the pancreas; patients with islet cell or other neuroendocrine neoplasms are excluded
Histologically or cytopathologically confirmed adenocarcinoma of the pancreas
Histologically documented Stage IV ductal adenocarcinoma of the pancreas
Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas
Histologically documented Stage IV ductal adenocarcinoma of the pancreas
Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas
Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies.
Histologically or cytologically proven adenocarcinoma of the pancreas; if the patient has mixed tumor with predominant adenocarcinoma pathology, they can be enrolled
Have histologically proven malignant adenocarcinoma of the pancreas; measurable disease is not required, mixed histology is not allowed; subjects must have metastatic disease
Received prior GVAX pancreas vaccine or CRS-207
Have histologically proven malignant adenocarcinoma of the pancreas; measurable disease is not required. (Subjects with mixed histology will be included if the predominant component is adenocarcinoma. Subjects must have metastatic disease.)
The subject has a resectable tumor or cyst arising from the pancreatic exocrine gland (pancreatic ductal adenocarcinoma, intraductal papillary mucinous neoplasm of the pancreas, or mucinous cystic neoplasm of the pancreas) and is undergoing surgical resection of the neoplasm
Phase Ib: Histologically or cytologically confirmed adenocarcinoma of the pancreas, colon or rectum which disease is advanced (defined as not surgically curable) or metastatic in whom combination treatment using fluorouracil, oxaliplatin and irinotecan is a rational option
Prior chemotherapy or radiation therapy of any kind for treatment of pancreas adenocarcinoma
Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
Histologically or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting
Patients who require any type of pancreas resection other than a distal pancreatectomy
All patients with metastatic pancreas cancer will be eligible
Patients who have tumors other than metastatic pancreas cancer
Previous partial or complete resection of the pancreas for adenocarcinoma
Histologically confirmed adenocarcinoma of the pancreas
Presence of suspicious lesion of the pancreas consistent with pancreatic adenocarcinoma; cytological confirmation is not required
Patients with primary or metastatic tumors in the lungs, liver, or pancreas
No prior therapy for pancreas cancer is allowed*