Clinical trial · Interventional
Feasibility Study of Short Term Fondaparinux (Arixtra) in Chemotherapy-Pretreated Ovarian Carcinoma Patients at High Risk of Progression
07-742 Phase I/ Feasibility Study of Short Term Fondaparinux (Arixtra) in Chemotherapy-Pretreated Ovarian Carcinoma Patients at High Risk of Progression
NCT00659399CI-TRIAL-00017157withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fondaparinux | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Estimate the proportion of patients who complete an eight week course of once daily administration of fondaparinux (Arixtra).
- timeFrame
- 15 months
Secondary outcomes (1)
- measure
- Time to Recurrence
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.