FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

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PRIMARY OBJECTIVES: I. To evaluate the overall survival (OS) of metastatic pancreatic cancer patients treated with fluorouracil, irinotecan (irinotecan hydrochloride), leucovorin (leucovorin calcium), (modified FOLFIRI) and ABT-888 (veliparib) compared to a control arm of fluorouracil, irinotecan, a...

PRIMARY OBJECTIVES: I. To evaluate the overall survival (OS) of metastatic pancreatic cancer patients treated with fluorouracil, irinotecan (irinotecan hydrochloride), leucovorin (leucovorin calcium), (modified FOLFIRI) and ABT-888 (veliparib) compared to a control arm of fluorouracil, irinotecan, and leucovorin (FOLFIRI). SECONDARY OBJECTIVES: I. To evaluate the frequency and severity of toxicity associated with each of the treatment arms in this patient population. II. To evaluate the progression-free survival (PFS) in each of the treatment arms in this patient population. III. To evaluate the overall response rate (confirmed and unconfirmed; complete response + partial response), disease control rate (confirmed and unconfirmed; complete response + partial response + stable disease), and duration of response in each of the treatment arms in this patient population. TERTIARY OBJECTIVES: I. To evaluate if breast cancer, early onset (BRCA)1 and BRCA2 mutations (somatic or germline) are associated with improved clinical outcomes (overall survival [OS], progression-free survival [PFS] and overall response rates [ORR]) in each treatment arm. II. To evaluate the impact of homologous recombination deficiency (HRD) score on clinical outcomes in each treatment arm. III. To evaluate the impact of genomic alterations identified by the BROCA-homologous recombinant (HR) assay, other than BRCA1/2, on clinical outcomes in each treatment arm. IV. To bank tissue for future translational medicine studies. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive veliparib orally (PO) twice daily (BID) every 12 hours on days 1-7, irinotecan hydrochloride intravenously (IV) over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5. ARM II: Patients receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 3 years.

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