Study on FOLFIRI or Modified FOLFIRI with Veliparib as Second-Line Treatment for Metastatic Pancreatic Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02890355

Provider View

This clinical trial is exploring whether adding the drug veliparib to a chemotherapy regimen called FOLFIRI can improve treatment outcomes for patients with metastatic pancreatic cancer that has returned after initial improvement.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with metastatic pancreatic cancer, which means the cancer has spread and returned after initial treatment. The trial compares two treatment options: one group will receive a combination of chemotherapy drugs (FOLFIRI), and the other group will receive the same chemotherapy drugs plus an additional drug called veliparib. Veliparib may help stop cancer cells from growing by blocking certain enzymes. The study aims to find out if the combination with veliparib is more effective than FOLFIRI alone.

Description

The main goal of this study is to see if adding veliparib to the chemotherapy regimen FOLFIRI can help patients with metastatic pancreatic cancer live longer. Researchers will also look at how often and how severe any side effects are, how long patients live without the cancer getting worse, and how well the cancer responds to the treatment.

The study will also explore whether certain genetic mutations, like BRCA1 and BRCA2, affect how well patients respond to the treatment. Tissue samples will be collected for future research.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will receive veliparib by mouth twice a day for 7 days, along with chemotherapy drugs irinotecan, leucovorin, and fluorouracil given through an IV on specific days.
  • Group 2: Will receive the same chemotherapy drugs without veliparib, given through an IV on specific days.

Both groups will receive treatment every 14 days as long as the cancer does not progress and side effects are manageable. After finishing the study treatment, participants will have follow-up visits every 3 months for 3 years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of pancreatic adenocarcinoma (a type of pancreatic cancer).
  • Cancer must have spread and be measurable by scans.
  • No history of cancer spreading to the brain.
  • Must have had only one previous treatment for metastatic cancer.
  • Must not have received certain chemotherapy or PARP inhibitor drugs before.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must meet specific blood test requirements for blood cell counts, liver and kidney function.
  • Must not have any major uncontrolled medical conditions.
  • Must be able to swallow pills.
  • Must not have known allergies to the study drugs.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must be willing to provide tissue and blood samples for research.
  • Must sign an informed consent form to participate in the study.

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