Overview

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Withdrawn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