Back to resultsStudy of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer
Primary Purpose
Advanced Ovarian Carcinoma, Primary Peritoneal Carcinoma, Ovarian Carcinosarcoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Avastin
Paclitaxel
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Ovarian Carcinoma focused on measuring Ovarian Cancer, Gynecologic Cancer, Ovarian Carcinoma, Peritoneal Carcinoma, IP chemotherapy, Intraperitoneal, Avastin, Bevacizumab
Eligibility 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.
Sites / Locations
- University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Avastin
Arm Description
Outcomes
Primary Outcome Measures
Number of Patients Able to Complete 6 Cycles of Treatment.
Completion of cycle 6
Secondary Outcome Measures
Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.
CTCAE assessment of toxicity
Full Information
NCT ID
NCT00511992
First Posted
August 3, 2007
Last Updated
June 2, 2017
Sponsor
University of Oklahoma
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00511992
Brief Title
Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 3, 2015 (Actual)
Study Completion Date
August 3, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Ovarian Carcinoma, Primary Peritoneal Carcinoma, Ovarian Carcinosarcoma
Keywords
Ovarian Cancer, Gynecologic Cancer, Ovarian Carcinoma, Peritoneal Carcinoma, IP chemotherapy, Intraperitoneal, Avastin, Bevacizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Avastin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Avastin
Other Intervention Name(s)
Bevacizumab
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75mg/m2 IP day 2 every 21 days x 6 cycles
Primary Outcome Measure Information:
Title
Number of Patients Able to Complete 6 Cycles of Treatment.
Description
Completion of cycle 6
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.
Description
CTCAE assessment of toxicity
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. Scott McMeekin, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer
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