A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer

Inclusion Criteria

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:

- Eastern Cooperative Oncology Group 0-2

Life expectancy:

- Not specified

Hematopoietic:

- White Blood Cell count 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

- aspartate aminotransferase 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