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Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)

NCT00239980 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2010-02-03

No results posted yet for this study

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

Interventions

DRUG

dalteparin

50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Laurie Elit, MD · Juravinski Cancer Centre

  • Agnes Lee, MD · Hamilton Health Sciences Henderson Division

  • Mark Levine, MD · McMaster University, Ontario Clinical Oncology Group

  • Jim Julian, MMath · McMaster University, Dept. of Clinical Epidemiology & Biostatistics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00239980 on ClinicalTrials.gov