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Dalteparin low molecular weight heparin ( LMWH ) in ovarian cancer : a phase II randomized study . OBJECTIVE Low molecular weight heparin reduces the risk of venous thromboembolism ( VTE ) and may have antineoplastic effects by interfering with angiogenesis and with tumor growth and metastasis . A multicentre phase II randomized trial was done to evaluate the antineoplastic potential of dalteparin in ovarian cancer ( OC ) . MATERIALS AND METHODS Women with newly-diagnosed epithelial OC were randomized to receive standard chemotherapy ( CT ) and one of 3 doses of dalteparin ( 50 IU/kg , 100 IU/kg , or 150 IU/kg ) subcutaneously once daily during the first 3 of 6 cycles of 3-weekly CT . Blood was drawn on day 1 of each cycle for CA125 and , in a substudy of randomized patients , for markers of coagulation activation and angiogenesis . The primary outcome was tumor response defined by ≥ 50 % reduction in serum CA125 from baseline sustained for at least 28 days . Patients were followed until the end of CT . RESULTS The study was terminated early due to poor recruitment . Seventy-seven women were evaluable for the primary outcome . A 50 % drop in CA125 at the end of cycle 3 was seen in 85 % of the 50 IU/kg group , 92 % of the 100 IU/kg group , and 85 % of the 150 IU/kg group . There were no symptomatic VTE or major bleeding events while on dalteparin . Two patients experienced VTE several days after discontinuing study drug . Women on dalteparin had lower levels of D-dimer and thrombin-antithrombin , and higher levels of tissue factor pathway inhibitor , relative to baseline . CONCLUSION Dalteparin is safe and well tolerated in women receiving CT for newly-diagnosed epithelial OC . A dose-response effect was not identified . The lack of control group precluded any inference on the antineoplastic effect of dalteparin .
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Intervention_Pharmacological
Dalteparin
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Intervention_Pharmacological
heparin
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Intervention_Pharmacological
dalteparin
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Intervention_Pharmacological
standard chemotherapy ( CT )
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Intervention_Pharmacological
dalteparin
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Outcome_Physical
tumor response defined by ≥ 50 % reduction in serum CA125
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Outcome_Physical
CA125
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Outcome_Adverse-effects
symptomatic VTE or major bleeding events
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Outcome_Adverse-effects
VTE
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Outcome_Physical
D-dimer and thrombin-antithrombin
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Participant_Condition
ovarian cancer
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Participant_Sex
Women
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Participant_Condition
newly-diagnosed epithelial OC
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Participant_Sample-size
Seventy-seven
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Participant_Sex
women