Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)

February 2, 2010 updated by: Ontario Clinical Oncology Group (OCOG)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • B.C. Cancer Agency- Fraser Valley Centre
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • B.C. Cancer Agency- Vancouver Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Hôpital Notre-Dame

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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. Any evidence of disease 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-study 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 at 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 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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
50 IU/kg
Drug: dalteparin
50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
Other Names:
  • brand name is fragmin
Active Comparator: B
100 IU/kg
Drug: dalteparin
50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
Other Names:
  • brand name is fragmin
Active Comparator: C
150 IU/kg
Drug: dalteparin
50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
Other Names:
  • brand name is fragmin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease response
Time Frame: up to day 1 of cycle 6
up to day 1 of cycle 6

Secondary Outcome Measures

Outcome Measure
Time Frame
symptomatic venous thromboembolism
Time Frame: up to 7 days after last dose of dalteparin
up to 7 days after last dose of dalteparin
bleeding
Time Frame: up to 24 hours after last dose of dalteparin
up to 24 hours after last dose of dalteparin
compliance
Time Frame: up to the end of cycle 3
up to the end of cycle 3
death
Time Frame: up to the last day of follow-up
up to the last day of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Pfizer

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (Estimate)

October 17, 2005

Study Record Updates

Last Update Posted (Estimate)

February 3, 2010

Last Update Submitted That Met QC Criteria

February 2, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRA6300011-FOCUS-II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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