Study on Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib for Treating Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer

Sponsor: Academic and Community Cancer Research United

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03337087

Provider View

This clinical trial is testing a combination of chemotherapy and a new drug, rucaparib, to see if it can effectively treat pancreatic, colorectal, gastroesophageal, or biliary cancer that has spread to other parts of the body. The study aims to find the best dose and evaluate how well the treatment works.

Patient Parameters

Program Overview

The purpose of this study is to determine the best dose and assess the effectiveness of a combination treatment using liposomal irinotecan, fluorouracil, leucovorin calcium, and rucaparib for patients with metastatic pancreatic, colorectal, gastroesophageal, or biliary cancer. These drugs work together to stop cancer cells from growing and repairing themselves. The study will evaluate how well this combination controls the disease and its side effects.

Description

This study is divided into two phases: Phase I and Phase II.

In Phase I, researchers will determine the safest and most effective dose of the combination treatment for patients with metastatic pancreatic, colorectal, gastroesophageal, or biliary cancer. Patients can have had a limited number of previous treatments for their cancer.

In Phase II, the study will focus on patients with pancreatic cancer that has specific genetic markers, such as BRCA1, BRCA2, or PALB2 mutations. The goal is to see how well the treatment works in controlling the cancer and improving survival rates.

Participants will receive the treatment in cycles, with each cycle lasting 28 days. The treatment includes intravenous (IV) administration of liposomal irinotecan, fluorouracil, and leucovorin calcium, along with oral doses of rucaparib. Patients will be monitored for side effects and the effectiveness of the treatment.

After completing the study treatment, participants will have follow-up visits every six months for three years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of metastatic pancreatic, colorectal, gastroesophageal, or biliary cancer.
  • Have received a limited number of previous treatments for their cancer, depending on the type of cancer.
  • Have measurable disease that can be tracked using standard criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1500/mm^3.
    • Platelet count of at least 100,000/mm^3.
    • Hemoglobin level of more than 9.0 g/dL.
    • Normal liver and kidney function as indicated by specific blood tests.
  • Women of childbearing potential must agree to use effective contraception during and for six months after treatment.
  • Provide informed consent and agree to return for follow-up visits.
  • Be willing to provide tissue and blood samples for research purposes.

Exclusion Criteria

  • Women who are pregnant or breastfeeding due to potential risks to the baby.
  • Have serious medical conditions that could interfere with the study.
  • Have a weakened immune system or are HIV positive and on antiretroviral therapy.
  • Have uncontrolled illnesses, such as heart failure or psychiatric conditions, that could affect participation.
  • Are currently receiving another investigational treatment for cancer.
  • Have had another type of cancer within the past three years, except for certain non-threatening cancers.
  • Have previously received treatment with PARP inhibitors, unless it was more than 12 months ago in an adjuvant setting.
  • Have a prolonged QT interval on an ECG, which could indicate heart rhythm problems.
  • Are unable to swallow pills.

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