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| Sponsor: | University of Oklahoma |
|---|---|
| Collaborator: |
Genentech |
| Information provided by (Responsible Party): | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00511992 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Ovarian Carcinoma Primary Peritoneal Carcinoma Ovarian Carcinosarcoma |
Drug: Avastin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Paclitaxel, Intraperitoneal Cisplatin and IV Bevacizumab Followed by Bevacizumab Consolidation for Advanced Ovarian and Peritoneal Carcinoma |
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Initial Treatment:
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, 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
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: | D. Scott McMeekin, MD | University of Oklahoma |
More Information
| Responsible Party: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00511992 History of Changes |
| Other Study ID Numbers: | AVF3953 McMeekin |
| Study First Received: | August 3, 2007 |
| Last Updated: | October 27, 2011 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Ovarian Cancer Gynecologic Cancer Ovarian Carcinoma Peritoneal Carcinoma |
IP chemotherapy Intraperitoneal Avastin Bevacizumab |
|
Carcinoma Carcinosarcoma Mixed Tumor, Mullerian Ovarian Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Complex and Mixed Sarcoma Neoplasms, Connective and Soft Tissue Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
