Ovarian CancerPhase 2NCT00239980
Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
A Phase 2 study testing dalteparin in people with Ovarian Cancer, run by Ontario Clinical Oncology Group (OCOG) at 9 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- dalteparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 9 sitesCanada
- Study dates
- Oct 2005to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
London Health Sciences Centre
London, Ontario, N6A 4G5
Hopital Notre-Dame
Montreal, Quebec, H2L 4M1
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
B.C. Cancer Agency- Fraser Valley Centre
Surrey, British Columbia, V3V 1Z2
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
B.C. Cancer Agency- Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: 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.
- Conditions
- Ovarian Cancer
- Being tested
- dalteparin
- Keywords
- antineoplastic agent, ovarian cancer, fragmin, dalteparin
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalteparinDrug
Also called brand name is fragmin
50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 50 IU/kg Receives: Drug: dalteparin |
| B | Active comparator | 100 IU/kg Receives: Drug: dalteparin |
| C | Active comparator | 150 IU/kg Receives: Drug: dalteparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease response
Measured: up to day 1 of cycle 6
Secondary outcomes (4)
symptomatic venous thromboembolism
Measured: up to 7 days after last dose of dalteparin
bleeding
Measured: up to 24 hours after last dose of dalteparin
compliance
Measured: up to the end of cycle 3
death
Measured: up to the last day of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Laurie Elit, MD, Study chair, Juravinski Cancer CentreAgnes Lee, MD, Study chair, Hamilton Health Sciences Henderson DivisionMark Levine, MD, Principal investigator, McMaster University, Ontario Clinical Oncology GroupJim Julian, MMath, Principal investigator, McMaster University, Dept. of Clinical Epidemiology & Biostatistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239980
- Sponsor's protocol ID
- NRA6300011-FOCUS-II
- Status last verified
- Feb 2010
- First submitted
- 13 Oct 2005
- Last updated
- 3 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33337539
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
- ClinicalTrials.gov ID
- NCT00239980
- Acronym / sponsor ID
- NRA6300011-FOCUS-II
- Conditions
- Ovarian Cancer
- Keywords
- antineoplastic agent, ovarian cancer, fragmin, dalteparin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: dalteparin50 IU/kg |
| B | Active comparator | Drug: dalteparin100 IU/kg |
| C | Active comparator | Drug: dalteparin150 IU/kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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:
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dalteparinAlso: brand name is fragmin50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy | Drug | A, B, C |
Primary outcome
disease response
Time frame: up to day 1 of cycle 6
4 secondary outcomes
symptomatic venous thromboembolism
Time frame: up to 7 days after last dose of dalteparin
bleeding
Time frame: up to 24 hours after last dose of dalteparin
compliance
Time frame: up to the end of cycle 3
death
Time frame: up to the last day of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2010.
- Derived from this study: PubMed 33337539Rutjes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dalteparin in people with Ovarian Cancer, run by Ontario Clinical Oncology Group (OCOG) at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease response (time frame: up to day 1 of cycle 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00239980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2010.