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

Metastatic Pancreatic Adenocarcinoma Clinical Trial

Official title: Randomized Phase II Study of 2nd Line FOLFIRI Versus Modified FOLFIRI With PARP Inhibitor ABT-888 (Veliparib) (NSC-737664) in Metastatic Pancreatic Cancer

Status Active, not recruiting

Clinical Trial Summary

This randomized phase II trial studies how well modified irinotecan hydrochloride, leucovorin calcium, fluorouracil (FOLFIRI) and veliparib as a second line of therapy work compared to FOLFIRI in treating patients with pancreatic cancer that has come back after a period of improvement (metastatic). Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether modified FOLFIRI and veliparib as second line therapy is more effective than FOLFIRI alone in treating metastatic pancreatic cancer.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Metastatic Pancreatic Adenocarcinoma
• Pancreatic Neoplasms
• Recurrent Pancreatic Carcinoma
• Stage IV Pancreatic Cancer AJCC v6 and v7

• NCT number: NCT02890355
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 1, 2016
• Completion date: March 5, 2025