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Treating Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer with Chemotherapy and Rucaparib

Treating Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer with Chemotherapy and Rucaparib

Clinicaltrials.gov identifier:
NCT03337087

Treatment:
Colorectal, Pancreatic

Study Contact Information:

For additional information, please contact the coordinating center at Mayo Clinic by phone: 855-776-0015

Principal Investigator: Tanios S. Bekaii-Saab


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

About the Study

This study is focused on patients with pancreatic, colorectal, gastroesophageal, or biliary (bile duct) cancer that has spread to other places in the body (metastasized).

Chemotherapy drugs, such as liposomal irinotecan and fluorouracil damage cancer cells. Targeted therapies such as rucaparib, can keep cancer cells from being able to repair damage.

This study will look at how the targeted therapy rucaparib works with chemotherapy in treating patients with metastatic pancreatic, colorectal, gastroesophageal, or biliary cancer. The study will measure the best dose and look at sides effects with this combination of drugs. 


Type of Study

This is a single-group, open-label study. That means all people in the study will receive the same combination of drugs.


What the Study Entails

Patients will receive these chemotherapy agents on days 1 and 15 of each cycle:

  • liposomal irinotecan intravenously (IV) over 90 minutes
  • leucovorin calcium IV
  • fluorouracil IV over 46 hours on days 1 and 15.

Patients also receive rucaparib orally twice daily on days 4-13 and 18-27 of each cycle

The cycle will repeat every 28 days as long as the cancer isn't growing and the patient doesn't have unacceptabled side effects.

After completion of study treatment, patients are followed up every 6 months for 3 years.


Study Sites

Arizona

  • Scottsdale: Mayo Clinic in Arizona
    Contact: Clinical Trial Referral Office by phone: 855-776-0015     
    Principal Investigator: Tanios S. Bekaii-Saab        

Georgia

  • Atlanta: Emory University Hospital/Winship Cancer Institute
    Contact: Christina S. Wu by phone: 404-778-0202 or by email 

Minnesota

  • Rochester: Mayo Clinic
    Contact: Clinical Trials Referral Office by phone: 855-776-0015 or by email              
    Principal Investigator: Wen Wee MA        
This Study is Open To:

Men and women age 18 years or older can participate if they meet the following criteria:

  • Have metastatic colorectal, pancreatic, gastroesophageal or biliary tract cancer that is not manageable by curative removal
  • Phase I only: Pancreatic, colorectal, gastroesophageal or biliary cancer, and:
    • Pancreatic cancer: patient has received no more than 2 lines of prior therapy in the metastatic setting
    • Colorectal cancer: patient has received no more than 3 lines of prior therapy in the metastatic setting
    • Gastroesophageal cancer: patient has received no more than 1 line of prior therapy in the metastatic setting
    • Biliary tract cancer: patient has received no more than 1 line of prior therapy in the metastatic setting
  • Phase Ib only: Patient with metastatic pancreatic cancer (with or without a BRCA1, BRCA2, or PALB2 mutation) who has received no more than 1 line of prior therapy
  • Phase II only: Patient with metastatic pancreatic cancer who also has a BRCA1, BRCA2, or PALB2 mutation, or a biomarker known as HRD (homologous recombination deficiency) with a BRCA1, BRCA2, or PALB2 mutation 
  • or has HRD (non-BRCA, non-PALB2) and has not received any systemic therapy in the metastatic setting
  • Are willing to provide tissue and blood samples
This Study is Not Open To:

Potential participants will be excluded who :

  • Are pregnant or nursing
  • Have a second severe disease or uncontrolled illness (in addition to cancer), such as an active infection, severe heart disease, or a psychiatric illness
  • Are immunocompromised and receiving therapy
  • Received any prior PARP inhibitor treatment