NCT00239980

Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)

A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Ontario Clinical Oncology Group (OCOG) · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	dalteparin	50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy

Timeline

• Start date: 2005-10-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2005-10-17
• Last updated: 2010-02-03

Locations

9 sites across 1 country: Canada