Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)

NCT00239980

Last updated date
Study Location
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovarian Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
Official Title  ICMJE A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Drug: dalteparin
50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
Other Name: brand name is fragmin
Study Arms  ICMJE
  • Active Comparator: A
    50 IU/kg
    Intervention: Drug: dalteparin
  • Active Comparator: B
    100 IU/kg
    Intervention: Drug: dalteparin
  • Active Comparator: C
    150 IU/kg
    Intervention: Drug: dalteparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2010)
77
Original Enrollment  ICMJE
 (submitted: October 13, 2005)
138
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00239980
Other Study ID Numbers  ICMJE NRA6300011-FOCUS-II
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Mark Levine, Ontario Clinical Oncology Group
Study Sponsor  ICMJE Ontario Clinical Oncology Group (OCOG)
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Laurie Elit, MDJuravinski Cancer Centre
Study Chair:Agnes Lee, MDHamilton Health Sciences Henderson Division
Principal Investigator:Mark Levine, MDMcMaster University, Ontario Clinical Oncology Group
Principal Investigator:Jim Julian, MMathMcMaster University, Dept. of Clinical Epidemiology & Biostatistics
PRS Account Ontario Clinical Oncology Group (OCOG)
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP