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.

Condition	Treatment or Intervention	Phase
recurrent pancreatic cancer stage IVA pancreatic cancer stage III pancreatic cancer stage IVB pancreatic cancer	Procedure: chemotherapy  Drug: cisplatin  Drug: fluorouracil  Drug: gemcitabine	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the overall survival in patients with unresectable stage III or IV pancreatic adenocarcinoma treated with gemcitabine, cisplatin, and fluorouracil. II. Determine the resectability rate with curative intent in patients with unresectable stage III pancreatic adenocarcinoma treated with this regimen. III. Assess the tolerability and toxicity of this treatment regimen in this patient population. IV. Evaluate this regimen in terms of response rate, response duration, and overall time to disease progression in these patients. V. Evaluate the quality of life in these patients.

PROTOCOL OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, followed by cisplatin IV over 30 minutes on days 1 and 15. Patients receive fluorouracil as a continuous infusion on days 1-15. Courses repeat every 28 days. Quality of life is assessed every 28 days.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States

Study chairs or principal investigators

Philip A. Philip,  Study Chair,  Barbara Ann Karmanos Cancer Institute   

Study ID Numbers:  CDR0000067213; WSU-D-1993; NCI-G99-1553; WSU-04-03-99-M01-FB
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00004003
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08