A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma

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