Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma

Study Overview
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Brief Summary
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Purpose of this study is to determine the effectiveness of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma.

Detailed Description
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The purpose of this study is to test the effectiveness, safety, and tolerability of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma. This is a phase II,open label,single center study. Patients will receive carboplatin, paclitaxel, and bevacizumab in an outpatient center by intravenous administration. The primary objectives is to study the progression free survival at 24 months after initiation of treatment and to determine the toxicity profile of the drug combinations. The secondary objectives are to estimate the overall survival and tumor response for this group of patients.

Official Title
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A Phase II Study of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Paclitaxel
* Drug: bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced Stage Endometrial Cancer (Stage 3 or 4) Any Histology including clear cell, and serous papillary carcinomas surgery must have had hysterectomy and bilateral salpingo-oophorectomy chemotherapy initiated 12 weeks after surgery sign informed consent Adequate End-organ function GOG (Gynecologic Oncology Group)Performance Status 0,1,2 Patients must be 18 years or older Patients may have received radiation for the treatment of endometrial cancer. Patients may have measurable or non-measurable disease. Exclusion Criteria: Patient with concomitant malignancy other than non-melanoma skin cancer Patients with prior malignancy who have been disease free for 5 years. Patients with serious uncontrolled infection, angina or serious peripheral neuropathy. Patients whose circumstances will not permit study completion or adequate follow up Patients who have received prior cytotoxic chemotherapy for treatment of endometrial cancer including chemotherapy used for radiation sensitization.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carboplatin/paclitaxel with bevacizumab<br>A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles. | Drug: Carboplatin<br>* AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.<br>* Other names: CBDCA;Drug: Paclitaxel<br>* 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.<br>* Other names: Taxol;Drug: bevacizumab<br>* 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate patients with progression free survival (PFS) |  | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate overall survival and objective tumor response using modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria |  | up to 24 months | 
| Number of patients with Adverse events as a measure of safety and tolerability. | Toxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0 | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial Cancer, Advanced Stage Endometrial Cancer, Stage 3 or 4 endometrial cancer, Cancer treatment, gyn cancer