Status:
WITHDRAWN
Feasibility Study of Short Term Fondaparinux (Arixtra) in Chemotherapy-Pretreated Ovarian Carcinoma Patients at High Risk of Progression
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Ovarian Carcinoma
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
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 o...
Detailed Description
Rationale: 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 pla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00659399
Start Date
January 1 2008
End Date
November 1 2010
Last Update
March 18 2015
Active Locations (1)
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1
NYU Cancer Institute Clinical Cancer Center
New York, New York, United States, 10016