Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer
Information source: University of Oklahoma
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Ovarian Carcinoma; Primary Peritoneal Carcinoma; Ovarian Carcinosarcoma
Intervention: Avastin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Oklahoma Official(s) and/or principal investigator(s):
D. Scott McMeekin, MD, Principal Investigator, Affiliation: University of Oklahoma
Overall contact:
Ingrid Block, RN, Phone: 405-271-8777, Email: ingrid-block@ouhsc.edu
Summary
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.
Clinical Details
Official title: Phase II Study of Paclitaxel, Intraperitoneal Cisplatin and IV Bevacizumab Followed by Bevacizumab Consolidation for Advanced Ovarian and Peritoneal Carcinoma
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Evaluating the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.
Secondary outcome: Describe toxicities associated with intraperitoneal cisplatin with intravenous paclitaxel and Avastin.
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Ingrid Block, RN, Phone: 405-271-8777, Email: ingrid-block@ouhsc.edu
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Recruiting
Additional Information
Starting date: July 2007
Ending date: July 2009
Last updated: August 1, 2008
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