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Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
dalteparin
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring antineoplastic agent, ovarian cancer, fragmin, dalteparin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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: Patient has a pelvic mass, AND Any evidence of disease larger than 1 cm in the upper abdomen (unless proven stage IV), AND Normal mammography within 6 weeks of randomization, AND 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: Absolute granulocyte count of at least 1.5 x 10 9/L (1500 per cubic millimetre). Platelet count of at least 150 x 109/L (100,000 per cubic millimetre). Serum creatinine no greater than 177 micromol/L (2.0 mg/dL). Total bilirubin level no greater than 1.5 times the upper limit of normal at the local centre. 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: Allergic reactions to drugs containing cremophor or compounds chemically related to taxanes or platinum analogues. Significant neurologic or psychiatric disorder that would impair obtaining informed consent and reliable follow-up. Uncontrolled hypertension despite optimal medical therapy. 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.

Sites / Locations

  • Cross Cancer Institute
  • B.C. Cancer Agency- Fraser Valley Centre
  • B.C. Cancer Agency- Vancouver Centre
  • Nova Scotia Cancer Centre
  • Juravinski Cancer Centre
  • London Health Sciences Centre
  • The Ottawa Hospital Cancer Centre
  • Princess Margaret Hospital
  • Hopital Notre-Dame

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

A

B

C

Arm Description

50 IU/kg

100 IU/kg

150 IU/kg

Outcomes

Primary Outcome Measures

disease response

Secondary Outcome Measures

symptomatic venous thromboembolism
bleeding
compliance
death

Full Information

First Posted
October 13, 2005
Last Updated
February 2, 2010
Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00239980
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
antineoplastic agent, ovarian cancer, fragmin, dalteparin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
50 IU/kg
Arm Title
B
Arm Type
Active Comparator
Arm Description
100 IU/kg
Arm Title
C
Arm Type
Active Comparator
Arm Description
150 IU/kg
Intervention Type
Drug
Intervention Name(s)
dalteparin
Other Intervention Name(s)
brand name is fragmin
Intervention Description
50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
Primary Outcome Measure Information:
Title
disease response
Time Frame
up to day 1 of cycle 6
Secondary Outcome Measure Information:
Title
symptomatic venous thromboembolism
Time Frame
up to 7 days after last dose of dalteparin
Title
bleeding
Time Frame
up to 24 hours after last dose of dalteparin
Title
compliance
Time Frame
up to the end of cycle 3
Title
death
Time Frame
up to the last day of follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: Patient has a pelvic mass, AND Any evidence of disease larger than 1 cm in the upper abdomen (unless proven stage IV), AND Normal mammography within 6 weeks of randomization, AND 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: Absolute granulocyte count of at least 1.5 x 10 9/L (1500 per cubic millimetre). Platelet count of at least 150 x 109/L (100,000 per cubic millimetre). Serum creatinine no greater than 177 micromol/L (2.0 mg/dL). Total bilirubin level no greater than 1.5 times the upper limit of normal at the local centre. 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: Allergic reactions to drugs containing cremophor or compounds chemically related to taxanes or platinum analogues. Significant neurologic or psychiatric disorder that would impair obtaining informed consent and reliable follow-up. Uncontrolled hypertension despite optimal medical therapy. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie Elit, MD
Organizational Affiliation
Juravinski Cancer Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Agnes Lee, MD
Organizational Affiliation
Hamilton Health Sciences Henderson Division
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mark Levine, MD
Organizational Affiliation
McMaster University, Ontario Clinical Oncology Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jim Julian, MMath
Organizational Affiliation
McMaster University, Dept. of Clinical Epidemiology & Biostatistics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
B.C. Cancer Agency- Fraser Valley Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
B.C. Cancer Agency- Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33337539
Citation
Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
Results Reference
derived

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Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)

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