Pancreatic Cancer Clinical Trial
Official title:
A Phase I(Limited)/Phase II Study of Oxaliplatin (OXAL) and Gemcitabine (GEMZAR) in Patients With Metastatic Pancreatic Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and oxaliplatin
in treating patients who have refractory locally advanced or metastatic pancreatic cancer.
OBJECTIVES: I. Determine the safety and tolerability of gemcitabine plus oxaliplatin in
patients with refractory metastatic or locally advanced pancreatic cancer (phase I portion
of the study closed as of 7/5/00). II. Determine the objective tumor response rate to this
combination regimen in this patient population.
OUTLINE: This is a dose escalation and efficacy study. Patients receive gemcitabine IV over
30 minutes on days 1 and 8 immediately followed by oxaliplatin IV over 2 hours on day 1.
Treatment repeats every 3 weeks. Patients achieving stable disease, partial response, or
regressive disease continue with therapy. Patients achieving complete response for two
consecutive evaluations receive an additional 2 courses of therapy. Phase I (closed as of
7/5/00): Cohorts of 3-6 patients receive escalating doses of gemcitabine and oxaliplatin
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 6 patients experience dose limiting toxicity. Phase II:
Patients receive the MTD of gemcitabine and oxaliplatin as in phase I. Patients are followed
every 3 months for 1 year, and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 32-52 patients (12 patients to phase I (phase I closed as of
7/5/00) and 20-40 to phase II) will be accrued for this study within approximately 11-28
months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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