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

Phase 2
18 Years
75 Years
Not Enrolling
Ovarian Cancer

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Trial Information

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

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

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease response

Outcome Time Frame:

up to day 1 of cycle 6

Safety Issue:


Principal Investigator

Laurie Elit, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Juravinski Cancer Centre


Canada: Health Canada

Study ID:




Start Date:

October 2005

Completion Date:

January 2010

Related Keywords:

  • Ovarian Cancer
  • antineoplastic agent
  • ovarian cancer
  • fragmin
  • dalteparin
  • Ovarian Neoplasms