Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
Summary
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.