Ovarian Carcinoma Clinical Trial
Official title:
07-742 Phase I/ Feasibility Study of Short Term Fondaparinux (Arixtra) in Chemotherapy-Pretreated Ovarian Carcinoma Patients at High Risk of Progression
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.
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
platelets and endothelial cells 2) stimulate tumor cell growth, 3) increase metastasis and
4) stimulate tumor angiogenesis.
Thrombin inhibition has anti-metastatic and anti-tumor activity in mouse models. Recent
meta-analysis of 4 major randomized clinical trials that have evaluated the effect of
anticoagulants on overall survival in cancer patients comparing low molecular weight heparin
(LMWH) to placebo demonstrates a 13% risk reduction in mortality at 1 year and 10% risk
reduction at 2 years, which is statistically significant and independent of the potential
confounding effect of anticoagulation in the prevention of venous thromboembolic disease.
Fondaparinux sodium (ARIXTRA® ) is a highly effective newer anticoagulant that is a fully
synthetic pentasaccharide. Arixtra binds to antithrombin III and subsequently inhibits
Factor Xa and hence thrombin generation. Arixtra has an excellent safety profile in clinical
trials of over 10,000 patients. When compared to LMWHs, ARIXTRA® has a potential
pharmacokinetic advantage based on its longer half-life of 16-17 hours.
Hypothesis:
The hypothesis to be tested is whether the completion of 8 weeks of 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 is feasible and safe and if the
inhibition of thrombin generation by ARIXTRA® in ovarian cancer will result in decrease
ovarian cancer recurrence.
A concise description of the methodology:
The trial will be a prospective open-label cohort feasibility study of giving 2 months of
ARIXTRA® in patients at high risk of recurrence of ovarian cancer. The planned accrual is 15
patients. Patients will be treated with a fixed dose of ARIXTRA® 2.5 mg by subcutaneous
injection once daily. Treatment will continue for 2 months or until disease recurrence or
grade 3 adverse events or patient refusal.
In addition, all patients will be followed for survival and recurrence.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05494580 -
Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT02530606 -
Photoacoustic Imaging in Detecting Ovarian or Fallopian Tube Cancer
|
N/A | |
| Active, not recruiting |
NCT02244502 -
Safety, Feasibility and Effect of TTFields (200 kHz) Concomitant With Weekly Paclitaxel in Recurrent Ovarian Carcinoma (INNOVATE)
|
Phase 1/Phase 2 | |
| Terminated |
NCT02218502 -
Study Into a New Diagnostic Tool (Simple Ultrasound-based Rules) in Patients With Adnexal Masses
|
N/A | |
| Terminated |
NCT01936974 -
(PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma
|
Phase 2 | |
| Recruiting |
NCT02073500 -
Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
|
||
| Completed |
NCT00756847 -
Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT02878980 -
An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical Outcomes of Platinum-Based Treatment in Ovarian Cancer Patients
|
N/A | |
| Active, not recruiting |
NCT02194387 -
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
|
N/A | |
| Recruiting |
NCT05001282 -
A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04251052 -
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
|
N/A | |
| Recruiting |
NCT04981119 -
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
|
||
| Completed |
NCT00989651 -
Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT05591560 -
Itraconazole in Advanced Ovarian Cancer
|
N/A | |
| Completed |
NCT01481701 -
A Trial Evaluating Efficacy and Safety of Oxaliplatin With 5-Fluorouracil in Patients With Recurrent Ovarian Carcinoma
|
Phase 2 | |
| Completed |
NCT00181701 -
Intraperitoneal Paclitaxel and Carboplatin in the Treatment of Women With Carcinoma of Mullerian Origin
|
Phase 2 | |
| Terminated |
NCT00047632 -
Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer
|
Phase 3 | |
| Recruiting |
NCT03302884 -
Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma
|
N/A | |
| Completed |
NCT02166905 -
DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04851119 -
Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
|
Phase 1/Phase 2 |