Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With Metastatic Cancer of the Pancreas

OBJECTIVES:

• Compare the overall survival rate of patients with metastatic pancreatic cancer treated with gemcitabine alone vs with cisplatin vs with docetaxel vs with irinotecan.
• Compare the time to disease progression in patients treated with these regimens.
• Compare the CA 19-9 biomarker response in patients treated with these regimens.
• Correlate the CA 19-9 biomarker response with survival in patients treated with these regimens.
• Compare the toxicity of these regimens in these patients.
• Compare the response in patients with measurable disease treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four treatment arms.

• Arm I: 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. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
• Arm III: Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 60 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
• Arm IV: Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 240 patients (60 per arm) will be accrued for this study within 30 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the pancreas
• Metastatic disease by CT scan

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• CTC 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• SGOT no greater than 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase less than 2.5 times ULN if SGOT greater than 1.5 times ULN
• Alkaline phosphatase any value if SGOT less than 1.5 times ULN

Renal:

• Creatinine no greater than 1.5 mg/dL

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study
• No other currently active malignancy (completed therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Chemotherapy:

• No prior chemotherapy except fluorouracil (5-FU)
• At least 2 weeks since prior 5-FU
• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy except steroids for adrenal failure, hormonal therapy for non-disease related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an antiemetic

Radiotherapy:

• At least 2 weeks since prior radiotherapy
• No concurrent palliative radiotherapy except whole-brain irradiation for CNS disease