Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed unresectable adenocarcinoma of the pancreas No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin Prior subtotal resection or gross residual disease No microscopic residual disease only No metastatic disease outside of planned study radiotherapy field PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able to maintain adequate oral nutrition No significant infection No other medical condition that would preclude study No other malignancy within the past 5 years except non-melanoma skin cancer No significant nausea or vomiting PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent biologic therapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy that would overlap planned study radiotherapy fields Surgery: See Disease Characteristics At least 21 days since prior laparotomy
Sites / Locations
- CCOP - Scottsdale Oncology Program
- MBCCOP - Howard University Cancer Center
- CCOP - Illinois Oncology Research Association
- Methodist Medical Center of Illinois
- CCOP - Carle Cancer Center
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- Siouxland Hematology-Oncology
- CCOP - Wichita
- CCOP - Ochsner
- CCOP - Michigan Cancer Research Consortium
- CCOP - Duluth
- Mayo Clinic Cancer Center
- CentraCare Health Plaza
- CCOP - Metro-Minnesota
- CCOP - Missouri Valley Cancer Consortium
- Medcenter One Health System
- CCOP - Merit Care Hospital
- Altru Cancer Center
- CCOP - Toledo Community Hospital
- CCOP - Geisinger Clinic and Medical Center
- Allegheny General Hospital
- Rapid City Regional Hospital
- CCOP - Sioux Community Cancer Consortium
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- Allan Blair Cancer Centre
Arms of the Study
Arm 1
Experimental
radiotherapy + gemcitabine + cisplatin
Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy. Patients are followed every 3 months for 2 years and then every 6 months for 1 year.