Gemcitabine Plus Oxaliplatin in Treating Patients With Refractory Locally Advanced or Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00004190
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gemcitabine + oxaliplatin gemcitabine hydrochloride 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. gemcitabine + oxaliplatin oxaliplatin 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.
- Primary Outcome Measures
Name Time Method overall response rate Up to 5 years
- Secondary Outcome Measures
Name Time Method objective tumor response Up to 5 years
Trial Locations
- Locations (19)
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Saskatchewan Cancer Agency
🇨🇦Regina, Saskatchewan, Canada
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Quain & Ramstad Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CentraCare Clinic
🇺🇸Saint Cloud, Minnesota, United States
CCOP - Geisinger Clinical and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States