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History of Changes for Study: NCT00239980
Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
Latest version (submitted February 2, 2010) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 13, 2005 None (earliest Version on record)
2 November 11, 2005 Study Status and Contacts/Locations
3 March 2, 2006 Contacts/Locations and Study Status
4 September 7, 2006 Contacts/Locations, Study Status and Eligibility
5 April 25, 2007 Study Status and Oversight
6 April 15, 2008 Contacts/Locations, Study Status, Eligibility and Study Design
7 April 29, 2008 Arms and Interventions, Contacts/Locations, Outcome Measures, Oversight, Sponsor/Collaborators and Study Status
8 July 8, 2008 Recruitment Status, Study Status and Contacts/Locations
9 February 2, 2010 Recruitment Status, Study Status and Study Design
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Study NCT00239980
Submitted Date:  October 13, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: NRA6300011-FOCUS-II
Brief Title: Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
Official Title: A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2005
Overall Status: Recruiting
Study Start: October 2005
Primary Completion:
Study Completion:
First Submitted: October 13, 2005
First Submitted that
Met QC Criteria:
October 13, 2005
First Posted: October 17, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 13, 2005
Last Update Posted: October 17, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Ontario Clinical Oncology Group (OCOG)
Responsible Party:
Collaborators: Pfizer
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Ovarian Cancer
Keywords: antineoplastic agent
ovarian cancer
fragmin
dalteparin
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 138
Open or close this module Arms and Interventions
Intervention Details:
Drug: dalteparin
Open or close this module Outcome Measures
Primary Outcome Measures:
1. disease response
Secondary Outcome Measures:
1. symptomatic venous thromboembolism
2. bleeding
3. compliance
4. death
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
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:
    1. Patient has a pelvic mass, AND
    2. Omental cake or other metastasis larger than 1 cm in the upper abdomen (unless proven stage IV), AND
    3. Normal mammography within 6 weeks of randomization, AND
    4. Serum CA-125/CEA greater than or equal to 25. 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 75.
  • FIGO stage IIB to IV disease.
  • A pre-treatment CA-125 level at least twice the upper limit of normal.
  • 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:
    1. Absolute granulocyte count of at least 1.5 x 10 9/L (1500 per cubic millimetre).
    2. Platelet count of at least 150 x 109/L (100,000 per cubic millimetre).
    3. Serum creatinine no greater than 177 micromol/L (2.0 mg/dL).
    4. Total bilirubin level no greater than 1.5 times the upper limit of normal of the local centre.
    5. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) levels no greater than 3 times the upper limit of normal of the local centre.

Exclusion Criteria:

  • Borderline ovarian tumours.
  • Received prior chemotherapy or radiation therapy.
  • Received mouse antibodies or have had medical or surgical interference with the peritoneum or pleura anytime during the 28 days prior to the pre-treatment CA-125 level.
  • History of another malignancy, except for non-melanomatous skin carcinoma or curatively treated carcinoma-in-situ of the cervix.
  • Eastern Cooperative Oncology Group (ECOG) performance score of 3 or 4.
  • 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).
  • Significant cardiac history including myocardial infarction within preceding 6 months, congestive heart failure, clinically relevant atrial or ventricular arrhythmias, history of 2nd or 3rd degree heart blocks unless pacemaker is implanted.
  • Serious medical conditions that preclude the administration of chemotherapy, anticoagulant therapy, or adherence to protocol, including but not exclusive to:
    1. Allergic reactions to drugs containing cremophor or compounds chemically related to taxanes or platinum analogues.
    2. Significant neurologic or psychiatric disorder that would impair obtaining informed consent and reliable follow-up.
    3. Uncontrolled hypertension despite optimal medical therapy.
    4. Active, uncontrolled infection.
  • Women who are pregnant or lactating or are of childbearing potential but are not using effective contraception.
  • Total body weight of less than 40 kg.
  • Concurrent treatment with experimental or investigational drugs.
  • Unable or unwilling to attend scheduled follow-ups.
  • Unable (e.g., language barrier, mental illness) to provide informed consent.
Open or close this module Contacts/Locations
Central Contact Person: Lorrie Costantini
Telephone: 905-527-2299 Ext. 42625
Email: costan@mcmaster.ca
Central Contact Backup: Lorna Holmes
Telephone: 905-527-2299 Ext. 43799
Email: lholmes@mcmaster.ca
Study Officials: Laurie Elit, MD
Study Chair
Juravinski Cancer Centre
Agnes Lee, MD
Study Chair
Hamilton Health Sciences Henderson Division
Mark Levine, MD
Principal Investigator
McMaster University, Ontario Clinical Oncology Group
Jim Julian, MMath
Principal Investigator
McMaster University, Dept. of Clinical Epidemiology & Biostatistics
Locations: Canada, Alberta
Tom Baker Cancer Centre
[Not yet recruiting]
Calgary, Alberta, Canada, T2N 4N2
Contact:Contact: Prafull Ghatage, MD 403-521-3721 prafullg@cancerboard.ab.ca
Contact:Principal Investigator: Prafull Ghatage, MD
Cross Cancer Institute
[Not yet recruiting]
Edmonton, Alberta, Canada, T6G 1Z2
Contact:Contact: Alex Schepansky, MB 780-432-8560 alexsche@cancerboard.ab.ca
Contact:Principal Investigator: Alex Schepansky, MD
Canada, British Columbia
B.C. Cancer Agency
[Not yet recruiting]
Vancouver, British Columbia, Canada, V5Z 4E6
Contact:Contact: Paul Hoskins, MD 604-877-6000 phoskins@bccancer.bc.ca
Contact:Principal Investigator: Paul Hoskins, MD
Canada, Manitoba
Cancer Care Manitoba
[Not yet recruiting]
Winnipeg, Manitoba, Canada, R2H 2A6
Contact:Contact: Robert Lotocki, MD 204-237-2547 rlotocki@mts.net
Contact:Principal Investigator: Robert Lotocki, MD
Canada, Newfoundland and Labrador
H. Bliss Murphy Cancer Centre
[Not yet recruiting]
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact:Contact: Lesa Dawson, MD 709-777-6564 ldawson@nctrf.nf.ca
Contact:Principal Investigator: Lesa Dawson, MD
Canada, Nova Scotia
Nova Scotia Cancer Centre
[Not yet recruiting]
Halifax, Nova Scotia, Canada, B3H 1V7
Contact:Contact: Robert Grimshaw, MD 902-473-2029 doctor@grimshaw.com
Contact:Principal Investigator: Robert Grimshaw, MD
Canada, Ontario
Juravinski Cancer Centre
[Recruiting]
Hamilton, Ontario, Canada, L8V 5C2
Contact:Contact: Laurie Elit, MD 905-387-9495 Ext. 64801 laurie.elit@hrcc.on.ca
Contact:Principal Investigator: Laurie Elit, MD
London Health Sciences Centre
[Not yet recruiting]
London, Ontario, Canada, N6A 4G5
Contact:Contact: Mark Carey, MD 519-685-8088 mark.carey@lhsc.on.ca
Contact:Principal Investigator: Mark Carey, MD
The Ottawa Hospital Regional Cancer Centre
[Not yet recruiting]
Ottawa, Ontario, Canada, K1H 8L6
Contact:Contact: Laura Hopkins, MD 613-737-8560 lahopkins@ottawahospital.on.ca
Contact:Principal Investigator: Laura Hopkins, MD
Toronto-Sunnybrook Regional Cancer Centre
[Not yet recruiting]
Toronto, Ontario, Canada, M4N 3M5
Contact:Contact: Al Covens, MD 416-480-4026 al.covens@sw.ca
Contact:Principal Investigator: Al Covens, MD
Princess Margaret Hospital
[Not yet recruiting]
Toronto, Ontario, Canada, M5G 2M9
Contact:Contact: Amit Oza, MD 416-946-2818 amit.oza@uhn.on.ca
Contact:Principal Investigator: Amit Oza, MD
Canada, Quebec
Hopital Notre-Dame
[Not yet recruiting]
Montreal, Quebec, Canada, H2L 4M1
Contact:Contact: Normand Blais, MD 450-668-1010 normand.blais@geoq.com
Contact:Principal Investigator: Normand Blais, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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