Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer. A Multicenter Randomized Phase III Trial.

Fecha de inicio: 1 de mayo de 1997

DISEASE CHARACTERISTICS: Histologic or cytologic proof of adenocarcinoma of the exocrine pancreas or of a metastasis associated with a radiologically identified pancreatic tumor Locally advanced and/or metastatic pancreatic cancer No measurable or evaluable target lesion is required No brain metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 40%-100% Hematopoietic: WBC at least 3,000/mm^3 Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 3 times normal Renal: Creatinine no greater than 1.24 mg/dL OR Creatinine clearance at least 80 mL/min Cardiovascular: No overt cardiac disease Other: No peripheral neuropathy No uncontrolled infectious or chronic disease No second primary except in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunologic therapy Chemotherapy: No prior chemotherapy allowed Endocrine therapy: No concurrent hormonal therapy At least 2 weeks since corticoid treatment Radiotherapy: No prior radiotherapy allowed except as an analgesic treatment on metastasis Surgery: Not specified