A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
Overview
- Phase
- Phase 2
- Intervention
- dalteparin
- Conditions
- Ovarian Cancer
- Sponsor
- Ontario Clinical Oncology Group (OCOG)
- Enrollment
- 77
- Locations
- 9
- Primary Endpoint
- disease response
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must meet all of the following criteria to be considered for enrolment:
- •Women with newly diagnosed, histologically proven EOC are potentially eligible. Patients with primary peritoneal or fallopian tube tumours of equivalent histology are also considered for enrolment. If open or true cut biopsy is not available, fine needle aspiration (FNA) showing an adenocarcinoma is considered diagnostic for EOC if all 4 (a to d) of the following conditions are satisfied:
- •Patient has a pelvic mass, AND
- •Any evidence of disease larger than 1 cm in the upper abdomen (unless proven stage IV), AND
- •Normal mammography within 6 weeks of randomization, AND
- •Serum CA-125/CEA greater than or equal to
- •If the ratio is less than 25, a barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) must be negative for a primary tumour.
- •Between the ages of 18 and
- •FIGO stage IIB to IV disease.
- •A pre-study CA-125 level at least twice the upper limit of normal.
Exclusion Criteria
- •Borderline ovarian tumours.
- •Received prior chemotherapy or radiation therapy for EOC.
- •Received mouse antibodies anytime during the 28 days prior to the pre-study CA-125 level.
- •History of another malignancy, unless disease-free for 5 years or greater; non-melanomatous skin carcinoma or curatively treated carcinoma-in-situ of the cervix are excepted.
- •Eastern Cooperative Oncology Group (ECOG) performance score of 3 or
- •Life expectancy less than 12 weeks.
- •Complete bowel obstruction at the time of study enrolment.
- •Receiving long-term anticoagulant therapy for an established indication (e.g., atrial fibrillation, mechanical heart valves).
- •Bleeding diathesis (e.g., evidence of DIC, hereditary or acquired bleeding disorder).
- •History of allergy to any heparin (e.g., heparin-induced thrombocytopenia).
Arms & Interventions
A
50 IU/kg
Intervention: dalteparin
B
100 IU/kg
Intervention: dalteparin
C
150 IU/kg
Intervention: dalteparin
Outcomes
Primary Outcomes
disease response
Time Frame: up to day 1 of cycle 6
Secondary Outcomes
- symptomatic venous thromboembolism(up to 7 days after last dose of dalteparin)
- bleeding(up to 24 hours after last dose of dalteparin)
- compliance(up to the end of cycle 3)
- death(up to the last day of follow-up)