SWOG clinical trial number
S1513

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

Closed
Phase
II
Accrual
86%
Abbreviated Title
RPh II of 2nd Line FOLFIRI w/ or w/o Veliparib (ABT888) in met panc cancer
Status Notes
Effective Immediately (12/13/2017) S1513 is permanently closed. Patients currently receiving ABT-888 (Veliparib) must discontinue the experimental treatment but may continue on FOLFIRI alone. Patients on both arms should continue study follow-up.
Activated
09/01/2016
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Research committees

Gastrointestinal Cancer

Treatment

5-Fluorouracil Irinotecan Leucovorin Calcium ABT-888

Eligibility Criteria Expand/Collapse

Histologically or cytologically documented pancreatic adenocarcinoma. Pancreatic neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible; Must have metastatic disease that is measurable, CT scans or MRIs of the chest, abdomen, and pelvis used to assess measurable disease must have been completed within 28 days prior to reg. CT Scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to reg.

Must not have history of brain mets; must have had one and only one prior regimen of systemic therapy for metastatic disease unless the patient 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; systemic therapy and chemoradiotherapy for tx of resectable, borderline resectable or locally advanced unresectable disease is allowed and does not count toward prior therapy for metastatic disease; must have completed systemic therapy at least 14 days prior to reg, any surgical procedure must have been performed at least 14 days prior to reg, and radiation therapy must be completed at least 7 days prior to reg. Patients must have recovered from major side effects of prior therapies or procedures in the opinion of the local site investigator prior to reg; must not have received prior irinotecan-based chemotherapy (e.g. FOLFIRINOX or FOLFIRI); must not have received prior PARP inhibitor therapy including, but not limited to ABT-888, olaparib, rucaparib, and BMN637; Zubrod PS of 0-1; >/= 18 years old; Within 14 days prior to reg: ANC >/ 1,500/mcL, hemoglobin >/= 9 g/dL, platelets >/= 100,000/mcL, total bilirubin </= 1.5 x IULN, serum albumin >/= 3/0 g/dL, AST and ALT </= 2.5 x IULN (pts w/liver mets may have AST and ALT of </= 5.0 x IULN), serum creatinine </= 2.0 mg/dL, normal CA19-9, BUN, alk phos, Na, K, Ca, glucose, Cl, & carbon dioxide; must not have clinically significant and uncontrolled major medical conditions including uncontrolled nausea/vomiting/diarrhea, active uncontrolled infection, symptomatic CHF (NYHA Class >/= II), unstable angina pectoris or cardiac arrhythmia, psychiatric illness/social situation that would limit compliance with study requirements; must not have active seizure or history of seizure; must be able to swallow whole capsule; complete physical exam and medical history w/in 28 days prior to reg; must not have known Gilbert's Syndrome; must not have known hypersensitivity to irinotecan, 5-FU, or leucovorin; pts of childbearing potential must have a negative pregnancy test w/in 28 days prior to reg and must not be nursing; must be willing to undergo biopsy after signed consent and prior to registration and submit tumor and blood samples Note: Core biopsy required, FNA is not an acceptable substitute for core biopsy; if archival tumor is available, pt must be willing to submit sample; must be offered the opportunity to participate in specimen banking for future use.

Publication Information Expand/Collapse

2020

Influence of Modeling Choices on Value of Information Analysis: An Empirical Analysis from a Real-world Experiment

DD Kim;G Guzauskas;C Bennette;A Basu;D Veenstra;S Ramsey;JJ Carlson PharmacoEconomics Feb;38(2):171-179; 2019 Oct 21. doi: 10.1007/s40273-019-00848-8. [Epub ahead of print]

PMid: PMID31631254

2019

Randomized Phase II Study of 2nd Line Modified FOLFIRI with PARP Inhibitor ABT-888 (Veliparib) (NSC-737664) vs FOLFIRI in Metastatic Pancreatic Cancer (mPC): SWOG S1513

EG Chiorean;K Guthrie;PA Philip;E Swisher;F Jalikis;M Pishvaian;J Berlin;MS Noel;JM Suga;I Garrido-Laguna;D Cardin;D Lew;A Lowy;H Hochster J Clin Oncol 37(suppl; abstr 4014); American Society of Clinical Oncology (5/31-6/4/19, Chicago IL), poster discussion

2018

Influence of Real-World Structural Assumptions on Value of Information (VOI) Analysis

DD Kim;G Guzauskas;C Bennette;D Veenstra;S Ramsey;J Carlson Society for Medical Decision Making (October 13-17, 2018, Montreal, Quebec, CAN ), poster

2017

Randomized phase II study of 2nd line FOLFIRI versus modified FOLFIRI with PARP inhibitor ABT-888 (Veliparib) (NSC-737664) in metastatic pancreatic cancer (mPC): SWOG S1513

EG Chiorean;S McDonough;PA Philip;E Swisher;M Pishvaian;K Guthrie;A Lowy;H Hochster J Clin Oncol 35, 2017 (suppl; abstr TPS4147); American Society of Clinical Oncology (ASCO) Annual Meeting(June 2-6, 2017, Chicago, IL), poster session

Other Clinical Trials

SWOG Clinical Trial Number
S1922

Randomized Phase II Study of Ramucirumab and Paclitaxel versus FOLFIRI in Refractory Small Bowel Adenocarcinoma

Research Committee(s)
Gastrointestinal Cancer
Activated
12/16/2019
Accrual
1%
Open
Phase
II
SWOG Clinical Trial Number
S1815
SWOG Clinical Trial Number
S1613