Gemcitabine Plus Oxaliplatin in Treating Patients With Refractory Locally Advanced or Metastatic Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, recurrent pancreatic cancer, duct cell adenocarcinoma of the pancreas, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ductal or undifferentiated primary pancreatic cancer for which no standard curative therapy exists Progressive locally advanced disease after combined chemotherapy and radiotherapy OR Not a candidate for combined therapy OR Metastatic disease No islet cell, acinar cell, or cystadenocarcinomas Measurable or evaluable disease No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina No cardiac arrhythmia Other: No other uncontrolled illness No active infection No allergy to platinum compounds, gemcitabine, or antiemetics No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No evidence of neuropathy except preexisting grade I or II Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy or immunotherapy No concurrent immunotherapy Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy, including cisplatin or gemcitabine, for radiosensitization in locally advanced disease No prior cisplatin or gemcitabine for locally advanced disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to 25% or more of bone marrow No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents
Sites / Locations
- CCOP - Scottsdale Oncology Program
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- Siouxland Hematology-Oncology
- CCOP - Wichita
- CCOP - Ann Arbor Regional
- CCOP - Duluth
- Mayo Clinic Cancer Center
- CentraCare Clinic
- CCOP - Missouri Valley Cancer Consortium
- Quain & Ramstad Clinic, P.C.
- CCOP - Merit Care Hospital
- CCOP - Toledo Community Hospital Oncology Program
- CCOP - Geisinger Clinical and Medical Center
- Rapid City Regional Hospital
- CCOP - Sioux Community Cancer Consortium
- Saskatchewan Cancer Agency
Arms of the Study
Arm 1
Experimental
gemcitabine + 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.