Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2008-04-01
• 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. It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced pancreatic cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Collaborator: Central European Cooperative Oncology Group
• Treatments: Capecitabine; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary inoperable or metastatic pancreatic adenocarcinoma

• No CNS metastases

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10.0 g/dL

Hepatic:

• Bilirubin no greater than 5 times normal

• AST/ALT no greater than 5 times normal

• Alkaline phosphatase no greater than 5 times normal

Renal:

• Creatinine clearance at least 30 mL/min

Gastrointestinal:

• No grade 2 or greater nausea or grade 1 or greater vomiting

• No medical condition that would interfere with taking oral medications or with gastrointestinal absorption (e.g., small bowel obstruction)

Other:

• No prior unanticipated severe reaction to fluoropyrimidine therapy

• No known hypersensitivity to fluorouracil

• No known dihydropyrimidine dehydrogenase deficiency

• No active infection

• No other serious concurrent systemic disorders that would preclude study participation

• No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior capecitabine

• No prior chemotherapy for advanced pancreatic cancer

• At least 1 year since prior radiochemotherapy for pancreatic cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• See Chemotherapy

• At least 1 year since prior adjuvant radiotherapy for pancreatic cancer

• No concurrent radiotherapy

Surgery:

• Prior Whipple procedure or duodenal bypass allowed

Other:

• At least 1 month since prior investigational agents

• No concurrent sorivudine or its chemically related analogues (e.g., brivudine)

• No other concurrent anticancer or investigational drugs