Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT03337087
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Metastatic Biliary Tract Carcinoma
  • Metastatic Colorectal Carcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Metastatic Malignant Digestive System Neoplasm
  • Metastatic Pancreatic Adenocarcinoma
  • Stage IV Colorectal Cancer AJCC v7
  • Stage IV Pancreatic Cancer AJCC v6 and v7
  • Stage IVA Colorectal Cancer AJCC v7
  • Stage IVB Colorectal Cancer AJCC v7

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fluorouracil — DRUG
    Given IV
  • Irinotecan Sucrosofate — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Leucovorin Calcium — DRUG
    Given IV
  • Rucaparib — DRUG
    Given PO

Study Details

This phase I/II trial studies the side effects and best dose of liposomal irinotecan and rucaparib when given together with fluorouracil and leucovorin calcium and to see how well they work in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as liposomal irinotecan, fluorouracil, and leucovorin calcium, 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. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as rucaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Giving liposomal irinotecan and rucaparib together with fluorouracil and leucovorin calcium may work better in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer.

Key Dates

Start date
Nov 2, 2018
Status verified
May 2024
Primary completion
Mar 31, 2021
Completion
Aug 9, 2025

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nal-IRI, leucovorin, fluorouracil, rucaparib)
    PHASE Ia: Patients receive liposomal irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV over 46 hours on days 1 and 15. Patients also receive rucaparib PO BID on days 4-13 and 18-27. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. PHASE Ib/II: Patients receive liposomal irinotecan IV over 90 minutes and fluorouracil IV over 46 hours on days 1 and 15. Patients also receive rucaparib PO BID on days 4-13 and 18-27. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (Phase I) [ Time Frame: Up to 28 days from start of treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic in Arizona· Scottsdale, AZEmory University Hospital/Winship Cancer Institute· Atlanta, GAMayo Clinic in Rochester· Rochester, MN

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