Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.

Detailed Description
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Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. The high death rate stems from late presentation and tumor that has spread beyond the ovary at the time of diagnoses. Ovarian cancer typically spreads throughout the peritoneal cavity. Three randomized clinical trial have recently demonstrated the superiority of intraperitoneal(IP) over intravenous platinum based chemotherapy in optimally debulked advance ovarian cancer. The success of Bevacizumab in metastatic colorectal cancer has led to trials evaluating its' efficacy in advanced ovarian cancer. Based on the mechanism of action of Bevacizumab, there may be benefit of extended therapy with this agent.

Official Title
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Phase II Study of Paclitaxel (TAXOL), Intraperitoneal Cisplatin and IV Avastin Followed by Avastin Consolidation for Advanced Ovarian and Peritoneal Carcinoma or Fallopian Tube Cancer

Conditions
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Advanced Ovarian Carcinoma, Primary Peritoneal Carcinoma, Ovarian Carcinosarcoma

Intervention / Treatment
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* Drug: Avastin
* Drug: Paclitaxel
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stage II and III epithelial ovarian carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma. Adequate bone marrow, renal, and hepatic function Patients must be entered no more than twelve weeks postoperatively Exclusion Criteria: Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas). Stage IV or suboptimally debulked disease following primary cytoreductive surgery Patients who have received prior radiotherapy or chemotherapy.

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: Avastin<br> | Drug: Avastin<br>* Initial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2) Consolidation Treatment: Avastin 15mg/kg IV every 21 days x 12 cycles<br>* Other names: Bevacizumab;Drug: Paclitaxel<br>* Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles<br>Drug: Cisplatin<br>* 75mg/m2 IP day 2 every 21 days x 6 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Able to Complete 6 Cycles of Treatment. | Completion of cycle 6 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin. | CTCAE assessment of toxicity | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cancer, Gynecologic Cancer, Ovarian Carcinoma, Peritoneal Carcinoma, IP chemotherapy, Intraperitoneal, Avastin, Bevacizumab