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

Withdrawn before enrolling · Phase 1

Conditions studied: Ovarian Carcinoma

In brief

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.

Key facts

Study ID

NCT00659399

Run by

NYU Langone Health

People needed

0

Starts

2008-01-01

Expected to finish

2010-11-01

Last updated by the study team

2015-03-18

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NYU Cancer Institute Clinical Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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