A Phase I(Limited)/Phase II Study of Oxaliplatin (OXAL) and Gemcitabine (GEMZAR) in Patients With Metastatic Pancreatic Carcinoma
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.
Interventional
Primary Purpose: Treatment
Steven R. Alberts, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000067431
NCT00004190
October 1999
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CentraCare Clinic | Saint Cloud, Minnesota 56303 |
Quain & Ramstad Clinic, P.C. | Bismarck, North Dakota 58501 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |