Clinical Trials

Title   SWOG 1513
Principal Investigator/ Physician   Moh’d Khushman, MD
Protocol No.   S1513
Open Date   05/09/2017
Cancer Site   Pancreatic
Status   Open
Sponsor   SWOG
Contact Email   MCI Clinical Trials
Summary  

Protocol: “Randomized Phase II Study of 2nd Line FOLFIRI versus Modified FOLFIRI with PARP Inhibitor ABT-888 (Veliparib) (NSC-737664) in Metastatic Pancreatic Cancer.”

Inclusion Criteria: Patients must have histologically or cytologically documented pancreatic adenocarcinoma; patients with pancreatic neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible; Patients must have metastatic disease that is measurable; Patients must have had one and only one prior regimen of systemic therapy for metastatic disease unless the patient meets the criteria below; Prior systemic therapy and chemoradiotherapy for treatment of resectable, borderline resectable or locally advanced unresectable disease is allowed and does not count toward prior therapy for metastatic disease; Patients who received systemic therapy with gemcitabine/nab-paclitaxel for resectable or borderline/locally advanced unresectable disease and progressed with metastatic disease within 3 months of the past dose of systemic therapy are eligible; Patients must have a Zubrod performance status of 0-1

Exclusion Criteria: History of brain metastases; received prior irinotecan-based chemotherapy; received prior PARP inhibitor therapy including, but not limited to ABT-888, olaparib, rucaparib, and talazoparib (BMN637); any clinically significant and uncontrolled major medical condition(s) including, but not limited to uncontrolled nausea/vomiting/diarrhea; active uncontrolled infection; symptomatic congestive heart failure (New York Heart Association [NYHA] class >= II); unstable angina pectoris or cardiac arrhythmia; psychiatric illness/social situation that would limit compliance with study requirements; active seizure or history of seizure; known Gilbert's syndrome; known hypersensitivity to irinotecan, fluorouracil, or leucovorin.

 

Clinical Trials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT02890355?term=S1513&recrs=a&rank=1 

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