• Quality of life as measured by FACT-Hep version 4 every 4 weeks [ Designated as safety issue: No ]
  

• Survival [ Designated as safety issue: No ]
  
• Frequency of symptomatic venous thromboembolic complications [ Designated as safety issue: No ]
  
• Safety as measured by the occurrence of bleeding complications [ Designated as safety issue: Yes ]
  

OBJECTIVES:

• Compare the quality of life of patients with unresectable or metastatic pancreatic cancer treated with gemcitabine with or without dalteparin.
• Compare the survival of patients treated with these regimens.
• Compare the incidence of venous thromboembolic complications in patients treated with these regimens.
• Determine the safety of dalteparin, in terms of bleeding complications, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (unresectable nonmetastatic vs metastatic). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 for the first course only. Beginning on week 9, patients receive gemcitabine IV over 30 minutes once weekly for 3 weeks. Treatment then repeats every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression.
• Arm II: Patients receive gemcitabine as in arm I and dalteparin subcutaneously once daily for 6 months in the absence of unacceptable toxicity.

Quality of life is assessed at baseline and every 4 weeks during study therapy.

Patients are followed every 4 weeks.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 40 months.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma of the pancreas that is considered ineligible for curative resection

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,500/mm^3
• Platelet count greater than 100,000/mm^3
• No clinically significant bleeding disorder
• No prior heparin-induced thrombocytopenia

Hepatic:

• Bilirubin less than 2.0 mg/dL
• AST less than 3 times normal

Renal:

• Creatinine less than 2.0 mg/dL

Cardiovascular:

• No prior hemorrhagic stroke
• No uncontrolled hypertension (sustained blood pressure greater than 200 mm Hg systolic or 110 mm Hg diastolic)

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other active malignancy
• No gastrointestinal bleeding within the past 30 days
• No contraindications to anticoagulation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for metastatic disease
• Prior adjuvant chemotherapy allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• Prior surgical resection allowed
• At least 4 weeks since prior surgery with non-curative intent and recovered
• More than 30 days since prior neurologic or ophthalmologic surgery

Other:

• At least 2 weeks since prior low-molecular-weight heparin
• More than 30 days since prior experimental therapeutic agent
• No concurrent heparin or warfarin for pre-existing condition