A Randomized, Open-Label, Multicenter Phase III Study Comparing the Efficacy and Safety of a Combination of Intravenous DX-8951f (Exatecan Mesylate) Plus Gemcitabine to Gemcitabine Alone in Patients With Locally Advanced or Metastatic Cancer of the Exocrine Pancreas Who Have Not Received Prior Chemotherapy

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas

- Locally advanced (unresectable) or metastatic disease

- No islet cell tumor, lymphoma, or sarcoma of the pancreas

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST no greater than 5 times ULN

- Albumin at least 2.8 g/dL

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No active congestive heart failure

- No uncontrolled angina

- No myocardial infarction

Other:

- No serious infection or life-threatening illness unrelated to tumor

- No other malignancy within the past 2 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No overt psychosis or incompetency that would preclude study

- No history of a positive serology for HIV

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior systemic anticancer immunotherapy for pancreatic cancer

- No concurrent anticancer immunotherapy or other biologic therapy

Chemotherapy:

- No prior systemic anticancer chemotherapy for pancreatic cancer

- Prior fluorouracil as a radiosensitizer allowed

- No prior gemcitabine as a radiosensitizer

- No other concurrent anticancer chemotherapy

Endocrine therapy:

- Concurrent megestrol for appetite stimulation allowed

Radiotherapy:

- At least 28 days since prior radiotherapy and recovered

- No prior radiotherapy to more than 25% of estimated bone marrow reserve

- No concurrent anticancer radiotherapy

Surgery:

- At least 28 days since prior major surgery and recovered

- No concurrent surgery for cancer

Other:

- No prior investigational or other systemic anticancer therapy for pancreatic cancer

- No other concurrent investigational drugs