Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Feasibility Study of Short Term Fondaparinux (Arixtra) in Chemotherapy-Pretreated Ovarian Carcinoma Patients at High Risk of Progression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00659399
Recruitment Status : Withdrawn (Low accrual)
First Posted : April 16, 2008
Last Update Posted : March 18, 2015
Information provided by:
NYU Langone Health

Brief Summary:
The purpose of this study is to assess feasibility and safety of using once daily Fondaparinux Sodium (ARIXTRA®) in patients with ovarian cancer who are in 'clinical remission' (no clinical evidence of disease) after chemotherapy but at high risk of ovarian cancer recurrence.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Drug: Fondaparinux Phase 1

Detailed Description:


A large body of work supports the association of abnormal coagulation (blood clot formation) and malignancy. A coagulation enzyme thrombin is able to 1) enhance cancer cell adhesion to platelets and endothelial cells 2) stimulate tumor cell growth, 3) increase metastasis and 4) stimulate tumor angiogenesis.

Thrombin inhibition has anti-metastatic and anti-tumor activity in mouse models. Recent meta-analysis of 4 major randomized clinical trials that have evaluated the effect of anticoagulants on overall survival in cancer patients comparing low molecular weight heparin (LMWH) to placebo demonstrates a 13% risk reduction in mortality at 1 year and 10% risk reduction at 2 years, which is statistically significant and independent of the potential confounding effect of anticoagulation in the prevention of venous thromboembolic disease.

Fondaparinux sodium (ARIXTRA® ) is a highly effective newer anticoagulant that is a fully synthetic pentasaccharide. Arixtra binds to antithrombin III and subsequently inhibits Factor Xa and hence thrombin generation. Arixtra has an excellent safety profile in clinical trials of over 10,000 patients. When compared to LMWHs, ARIXTRA® has a potential pharmacokinetic advantage based on its longer half-life of 16-17 hours.


The hypothesis to be tested is whether the completion of 8 weeks of ARIXTRA® in patients with ovarian cancer who are in 'clinical remission' (no clinical evidence of disease) after chemotherapy but at high risk of ovarian cancer recurrence is feasible and safe and if the inhibition of thrombin generation by ARIXTRA® in ovarian cancer will result in decrease ovarian cancer recurrence.

A concise description of the methodology:

The trial will be a prospective open-label cohort feasibility study of giving 2 months of ARIXTRA® in patients at high risk of recurrence of ovarian cancer. The planned accrual is 15 patients. Patients will be treated with a fixed dose of ARIXTRA® 2.5 mg by subcutaneous injection once daily. Treatment will continue for 2 months or until disease recurrence or grade 3 adverse events or patient refusal.

In addition, all patients will be followed for survival and recurrence.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 07-742 Phase I/ Feasibility Study of Short Term Fondaparinux (Arixtra) in Chemotherapy-Pretreated Ovarian Carcinoma Patients at High Risk of Progression
Study Start Date : January 2008
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : November 2010

Intervention Details:
  • Drug: Fondaparinux
    Arixtra 2.5 mg by subcutaneous injection once daily for 8 weeks or until disease recurrence or grade 3, 4 adverse events.
    Other Names:
    • Arixtra
    • fondaparinux sodium

Primary Outcome Measures :
  1. Estimate the proportion of patients who complete an eight week course of once daily administration of fondaparinux (Arixtra). [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. Time to Recurrence [ Time Frame: 24 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients 18 years of age and ≤75 years of age
  • Biopsy-proven ovarian, tubal or primary peritoneal epithelial adenocarcinomas;
  • Performance status 0,1 (ECOG) ( table 2)
  • Patients at high risk of clinical relapse: first remission stage III/IV who were suboptimally debulked (residual disease >1 cm)
  • Patients of any stage who have recurred and are in second chemotherapy induced remission. Clinical remission defined as:

    • absence of symptoms that may be related to disease
    • imaging without abnormalities greater then or equal to 1 cm suspicious for disease (no ascites)
    • CA 125 obtained x 1 and <35 units/ml.
  • Adequate end organ function, defined as the following:

    • Total bilirubin < 1.5 x ULN
    • SGOT and SGPT < 2.5 x UNL
    • Creatinine < 1.5 x ULN
    • ANC > 1.5 x 109/L
    • Platelets > 100 x 109/L
    • Weight ≥ 50 kg

Exclusion Criteria:

  • Patients with performance status ECOG =2,3,4
  • Patients who are on warfarin or prior therapeutic anticoagulation
  • Patient has another primary malignancy that has required active intervention within 5 years, with the exception of basal cell skin cancer or a cervical carcinoma in situ.
  • Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
  • Patient who had a major surgery within 2 weeks prior to study entry
  • Patients with the following lab abnormalities:

    • WBC <3000
    • absolute neutrophil count < 1,500
    • hemoglobin <10 g/dL
    • platelet < 100,000
    • creatinine clearance <30 cc/min
    • serum ALT, AST, or total bilirubin >1.5X the upper limit of normal
  • Patients with known bleeding disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00659399

Layout table for location information
United States, New York
NYU Cancer Institute Clinical Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Layout table for investigator information
Principal Investigator: Boris Kobrinsky, M.D. NYU School of Medicine
Layout table for additonal information
Responsible Party: Boris Kobrinsky, New York University Cancer Institute Identifier: NCT00659399    
Other Study ID Numbers: 07-742
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by NYU Langone Health:
Pretreated Ovarian Carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents