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Research & Clinical Trials > Study Search Tool > Chemotherapy/PARP Inhibitor Combination for Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer

Chemotherapy/PARP Inhibitor Combination for Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer

This study is open to:

Men and women with:

  • Phase I:
    • Confirmation of metastatic pancreatic, colorectal, gastroesophageal or biliary adenocarcinoma.  
      • Patients with pancreatic cancer who have received no more than 2 prior lines of therapy in the metastatic setting
      • ​Patients with colorectal cancer who received no more than 3 prior lines of therapy in the metastatic setting
      • Patients with gastroesophageal cancer or biliary tract cancer who received no more than 1 prior line of therapy in the metastatic setting
    • Phase Ib: Confirmation of metastatic pancreatic or gastroesophageal adenocarcinoma, with no prior exposure to irinotecan in a metastatic setting
  • Phase II:
    • Metastatic pancreatic cancer in patients with a BRCA1BRCA2 or PALB2 mutation, or tumor biomarkers known as HRD who have not received any systemic therapy for their metastatic cancer. 
  • All patients must be willing to provide tissue and blood samples
This study is not open to:

People will be excluded who:

  • Received any prior PARP inhivitor treatment
  • Have any other systemic illnesses, infection or disease 
  • Are immunocompromised  
  • Received any other investigational agent which would be considered as a treatment for the primary cancer
  • Were diagnosed with another cancer < 3 years prior to joining the study EXCEPT for curatively treated cervical cancer in situ, melanoma in situ, non-melanoma skin cancer and superficial bladder tumors
Chemotherapy/PARP Inhibitor Combination for Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer

Chemotherapy and PARP Inhibitor for Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer

Clinicaltrials.gov identifier:
NCT03337087

Treatment:
Pancreatic

Study Contact Information

For additional information, please contact the coordinating center at:
Clinical Trial Referral Office  by phone:  855-776-0015 or the Principal Investigator Tanios S. Bekaii-Saab by email.   

About the Study

This clinical trial studies a combination of drugs to learn the best dose, side effects, and how well they work together for treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer that has spread to other places in the body.  

Type of Study

This is a single-arm, open-label study,

  • The study only has one treatment arm. This means that all patients who enroll in the trial will receive all study medications.

This study will be conducted in two phases. 

  • Phase I
    • The initial Phase 1 study will establish the recommended dose level for the phase Ib and phase II trial of liposomal irinotecan (nal-IRI) and fluorouracil (5-FU) with rucaparib (MFR) in patients with metastatic pancreatic cancer, colorectal cancer, gastroesophageal cancer and biliary tract cancer.
    • Phase Ib will assess results of the recommended dose level of combination of nal-IRI and 5-FU with rucaparib in patients with metastatic pancreatic cancer and gastroesophageal cancer.
  • Phase II will estimate the proportion of study participants with metastatic pancreatic cancer and a BRCA1, BRCA2, or PALB2 mutation in their tumors who achieve complete response vs. partial response after receiving the study treatments. 

What the Study Entails

  • Patients receive liposomal irinotecan, leucovorin calcium IV, and fluorouracil intravenously on days 1 and 15.
  • Patients also receive rucaparib orally twice daily on days 4-13 and 18-27.
  • Courses repeat every 28 days in the absence of disease progression or you experience intolerable side effects.
  • After completion of study treatment, patients are followed up for 3 years.

Study Sites

  • Arizona
    • Scottsdale, AZ
  • Georgia
    • Atlanta, GA
      • Emory University Hospital/Winship Cancer Institute
      • Contact: Contact: Christina S. Wu by email or by phone: 404-778-0202     
  • Minnesota
    • Rochester
      • Mayo Clinic
      • Contact Clinical Trials Referral Office    855-776-0015
      • Site PI: Wen Wee MA, MD   

Principal Investigator

 

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