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

• Status: Withdrawn
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: GlaxoSmithKline
• Treatments: Fondaparinux; PENTA

Criteria

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