Trial Information

Phase III Double-Blind Trial Comparing Low-Molecular Weight Heparin (LMWH) Versus Placebo in Patients With Advanced Cancer

OBJECTIVES: I. Compare the effect of low molecular weight heparin (dalteparin) plus standard
therapy versus standard therapy alone on the overall survival rate of patients with advanced
cancers. II. Compare the toxic effects of these regimens and the effect on the quality of
life of these patients. III. Assess the incidence of symptomatic thrombotic events such as
deep venous thrombosis (DVT), pulmonary embolus (PE), and clotted catheters in these
patients.

OUTLINE: This is a randomized study. Patients are stratified according to prognostic index
(good vs bad vs unsure), current therapy (systemic vs radiation vs both vs none), age (50 or
under vs over 50), disease site (breast vs colon vs small cell lung vs nonsmall cell lung vs
prostate), history of prior thrombotic event over 1 year ago (yes vs no), and gender.
Patients are randomized to receive low molecular weight heparin (dalteparin) plus standard
therapy or standard therapy alone. Patients receive dalteparin by subcutaneous injection
once daily plus standard therapy or standard therapy alone. Treatment continues for 1 year
in the absence of disease progression and unacceptable toxicity. Quality of life is assessed
before treatment, then every month for the first year, and then every 3 months for 2 years.
Patients are followed monthly for 1 year, then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 556 patients (278 per arm) will be accrued for this study
within 19 months.