Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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. It is not yet known whether docetaxel plus gemcitabine is more effective than docetaxel plus cisplatin in treating advanced pancreatic cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel and gemcitabine with that of docetaxel and cisplatin in treating patients who have metastatic or locally advanced pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Cisplatin; Docetaxel; Gemcitabine

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or locoregionally advanced (with metastatic lymph nodes) unresectable adenocarcinoma of the exocrine pancreas Bidimensionally measurable disease outside previously irradiated fields No CNS involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times the upper limit of normal (ULN) Renal: Creatinine no greater than ULN Other: No prior second malignancy in the past 10 years except carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin No psychological, familial, sociological, or geographical condition that precludes study compliance Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy allowed if indicator lesions not included in irradiated field See Disease Characteristics Surgery: Not specified Other: No concurrent investigational drugs