Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma or poorly differentiated carcinoma
• •Ineligible for curative resection
• •Measurable and/or nonmeasurable disease
• •Must have evidence of disease outside prior radiation fields OR radiologically confirmed progression of disease within the radiation fields after completion of radiotherapy
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •WBC ≥ 3,500/mm\^3 OR
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 125,000/mm\^3
• •Hepatic
• •Bilirubin \< 2.0 mg/dL
• •AST \< 3 times upper limit of normal (ULN)
• •Renal
• •Creatinine ≤ 1.5 times ULN
• •Cardiovascular
• •No uncontrolled cardiac disease
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •* Negative vaginal ultrasound for patients with an elevated beta human chorionic gonadotropin level
• •Fertile patients must use effective nonhormonal contraception
• •No other malignancies within the past 5 years except nonmetastatic, nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy
• •No active or uncontrolled infection
• •No other active illness that would preclude study participation
• •No symptomatic sensory peripheral neuropathy ≥ grade 2
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Not specified
• •Chemotherapy
• •No prior chemotherapy for metastatic disease
• •No prior (including adjuvant) gemcitabine or oxaliplatin
• •Prior adjuvant chemotherapy allowed provided there was more than 6 months between the last dose of adjuvant chemotherapy and recurrence of pancreatic cancer
• •Prior chemotherapy as a radiosensitizing agent allowed\* NOTE: \*To the primary site
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •See Disease Characteristics
• •At least 4 weeks since prior radiotherapy to the primary tumor site and recovered
• •No prior radiotherapy to more than 25% of the functional bone marrow
• •Surgery
• •See Disease Characteristics
• •Prior surgical resection allowed
• •Other
• •No concurrent participation in supportive care trials
• •Concurrent enrollment on protocol ECOG-E1Y03 allowed