Epithelial ovarian carcinoma (EOC) is the 5th leading cause of death among women. Long-term survival is poor for the majority of women with EOC because many present with advanced disease. Chemotherapy and cytoreductive surgery produces a 50% - 60% response rate but relapse is not uncommon. Adding more systemic agents has failed to show a clear benefit in survival and is associated with unacceptable toxicity. This phase II, dose-finding, open label trial will enrol women with newly diagnosed EOC and randomize them to receive one of 3 doses of a LMWH dalteparin in conjunction with standard adjuvant taxane- and platinum-based chemotherapy. The primary outcome is disease response, measured according to Gynaecologic Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 response criteria. Secondary outcomes include symptomatic venous thromboembolism, bleeding, and compliance. The dose of dalteparin associated with the best response will be tested further in a phase III randomized clinical trial in the same patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
Cross Cancer Institute
Edmonton, Alberta, Canada
B.C. Cancer Agency- Fraser Valley Centre
Surrey, British Columbia, Canada
B.C. Cancer Agency- Vancouver Centre
Vancouver, British Columbia, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital Notre-Dame
Montreal, Quebec, Canada
disease response
Time frame: up to day 1 of cycle 6
symptomatic venous thromboembolism
Time frame: up to 7 days after last dose of dalteparin
bleeding
Time frame: up to 24 hours after last dose of dalteparin
compliance
Time frame: up to the end of cycle 3
death
Time frame: up to the last day of follow-up
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