Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery

• Status: Completed
• Trial end date: 2003-08-01
• 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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating adult patients who have stage III or stage IV pancreatic cancer that cannot be removed by surgery.

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

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Fluorouracil; Gemcitabine

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed pancreatic adenocarcinoma Unresectable locally advanced (stage III) OR Metastatic (stage IV) Gallbladder or biliary tract cancer allowed No endocrine tumors or lymphoma of the pancreas No CNS metastases

PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST no greater than 3.0 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other: No active infection No other serious systemic disorders No other active malignancies within the past year except curatively treated basal cell skin cancer or carcinoma in situ of the cervix Must have central venous access device (i.e., Infusaport or PASPORT) Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for locally advanced or metastatic disease At least 6 months since prior adjuvant chemotherapy No prior gemcitabine Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics