A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
Multi-agent chemotherapy has value for patients with advanced pancreatic-biliary cancers
leading to responses in a substantial minority and increasing survival. The use of the
FOLFIRINOX regimen is limited by its' intensity and toxicity. Previous protocol and clinical
experience within the University of Michigan Pancreatic Program leads to an expectation of
tolerance and efficacy of the proposed regimen. Advantages of the proposed regimen relative
to FOLFIRINOX include:
1. Substitution of gemcitabine for irinotecan. Single agent activity of gemcitabine is at
least as good as irinotecan (probably better, especially when delivered by FDR
[fixed-dose rate] infusion) and gemcitabine is much better tolerated with less diarrhea,
nausea/emesis, myelosuppression and alopecia.
2. Deletion of leucovorin infusion and 5FU bolus injection will lessen myelosuppression,
mucositis and diarrhea.
3. Substitution of cisplatin for oxaliplatin will reduce cost of therapy and avoid cold
aggravated dysesthesia.
Presuming evidence of efficacy and confirmation of tolerance with the proposed regimen, the
investigators believe this treatment may be more widely applicable to pancreatic-biliary
cancer patients, including those with advanced disease as well as being considered for use in
locally advanced and neo- and adjuvant settings.
Phase:
Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center