Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00239980
First received: October 13, 2005
Last updated: February 2, 2010
Last verified: February 2010
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • disease response [ Time Frame: up to day 1 of cycle 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • symptomatic venous thromboembolism [ Time Frame: up to 7 days after last dose of dalteparin ] [ Designated as safety issue: Yes ]
  • bleeding [ Time Frame: up to 24 hours after last dose of dalteparin ] [ Designated as safety issue: Yes ]
  • compliance [ Time Frame: up to the end of cycle 3 ] [ Designated as safety issue: No ]
  • death [ Time Frame: up to the last day of follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 77
Study Start Date: October 2005
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
50 IU/kg
Drug: dalteparin
50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
Other Name: 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 Name: 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 Name: brand name is fragmin

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239980

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

No publications provided

Responsible Party: Dr. Mark Levine, Ontario Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00239980     History of Changes
Other Study ID Numbers: NRA6300011-FOCUS-II
Study First Received: October 13, 2005
Last Updated: February 2, 2010
Health Authority: Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):
antineoplastic agent
ovarian cancer
fragmin
dalteparin

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antineoplastic Agents
Dalteparin
Heparin, Low-Molecular-Weight
Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 18, 2014