A Two-Part Phase I Study of the Addition of Oxaliplatin to Gemcitabine, and Then Erlotinib Plus Oxaliplatin to Gemcitabine as Radiosensitizers for Pancreatic and Biliary Adenocarcinoma
- Determine the maximum tolerated dose (MTD) of oxaliplatin and gemcitabine hydrochloride
when combined with radiotherapy in patients with unresectable and/or metastatic
pancreatic or biliary tract adenocarcinoma. (Part 1)
- Determine the MTD of erlotinib hydrochloride and gemcitabine hydrochloride when
combined with oxaliplatin at the MTD and radiotherapy in these patients. (Part 2)
OUTLINE: This is a multicenter, nonrandomized, parallel group, uncontrolled, open-label,
dose-escalation study of gemcitabine hydrochloride, oxaliplatin, and erlotinib
- Part 1: Patients receive gemcitabine hydrochloride IV over 30-60 minutes and
oxaliplatin IV on day 1. Patients also undergo external beam radiotherapy (EBRT) once
daily on days 1-5. Treatment repeats every 7 days for up to 6 courses.
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and
oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
(DLT). Up to 10 patients are treated at the MTD.
- Part 2: Patients receive gemcitabine hydrochloride, oxaliplatin*, and EBRT as in part
1. Patients also receive oral erlotinib hydrochloride once daily on days 1-5. Treatment
repeats every 7 days for up to 6 courses.
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and erlotinib
hydrochloride until the MTD is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience DLT. Up to 10 patients are treated at the MTD.
NOTE: *Patients receive oxaliplatin at the MTD determined in part 1.
After completion of study treatment, patients are followed every 3 months.
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of oxaliplatin and gemcitabine hydrochloride (Part 1)
The MTC of Oxaliplatin and gemcitabine is defined as the combination for which the rate of toxicities that cause dose reductions plus twice the rate of dsoe limiting toxicity (DLT) is equal to 0.5
Bert H. O'Neil, MD
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
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