Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Ontario Clinical Oncology Group (OCOG) Pfizer |
---|---|
Information provided by: | Ontario Clinical Oncology Group (OCOG) |
ClinicalTrials.gov Identifier: | NCT00239980 |
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.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer |
Drug: dalteparin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS) |
Estimated Enrollment: | 138 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
50 IU/kg
|
Drug: dalteparin
50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
|
B: Active Comparator
100 IU/kg
|
Drug: dalteparin
50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
|
C: Active Comparator
150 IU/kg
|
Drug: dalteparin
50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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:
Eligible for standard adjuvant treatment with taxane- and platinum-based chemotherapy by meeting all of the following laboratory findings within 7 days prior to randomization:
Exclusion Criteria:
Serious medical conditions that preclude the administration of chemotherapy, anticoagulant therapy, or adherence to protocol, including but not exclusive to:
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Canada, British Columbia | |
B.C. Cancer Agency- Vancouver Centre | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
B.C. Cancer Agency- Fraser Valley Centre | |
Surrey, British Columbia, Canada, V3V 1Z2 | |
Canada, Nova Scotia | |
Nova Scotia Cancer Centre | |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Canada, Ontario | |
Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
The Ottawa Hospital Cancer Centre | |
Ottawa, Ontario, Canada, K1H 8L6 | |
London Health Sciences Centre | |
London, Ontario, Canada, N6A 4G5 | |
Canada, Quebec | |
Hopital Notre-Dame | |
Montreal, Quebec, Canada, H2L 4M1 |
Study Chair: | Laurie Elit, MD | Juravinski Cancer Centre |
Study Chair: | Agnes Lee, MD | Hamilton Health Sciences Henderson Division |
Principal Investigator: | Mark Levine, MD | McMaster University, Ontario Clinical Oncology Group |
Principal Investigator: | Jim Julian, MMath | McMaster University, Dept. of Clinical Epidemiology & Biostatistics |
Responsible Party: | Ontario Clinical Oncology Group ( Dr. Mark Levine ) |
Study ID Numbers: | NRA6300011-FOCUS-II |
Study First Received: | October 13, 2005 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00239980 |
Health Authority: | Canada: Health Canada |
antineoplastic agent ovarian cancer fragmin dalteparin |
Genital Diseases, Female Ovarian cancer Ovarian Neoplasms Dalteparin Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Endocrinopathy Ovarian Diseases Endocrine Gland Neoplasms |
Fibrin Modulating Agents Neoplasms Anticoagulants Neoplasms by Site Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions Adnexal Diseases |