Pancreatic Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and gemcitabine, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor
cells. Giving oxaliplatin together with gemcitabine, erlotinib, and radiation therapy may
kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin,
gemcitabine, and erlotinib when given together with radiation therapy in treating patients
with unresectable and/or metastatic pancreatic cancer or biliary tract cancer.
OBJECTIVES:
- 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
hydrochloride.
- 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
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