Back to resultsPh II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers
Primary Purpose
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topotecan
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring platinum resistant ovarian cancer, recurrent ovarian cancer, platinum resistant cancer
Eligibility Criteria
Inclusion Criteria: must have received primary taxane and platinum-based chemotherapy and no more than 1 other chemotherapy regimen must have platinum resistant disease(defined as recurrence within 6 months of receiving platinum based chemotherapy, first or second line) must have measurable disease (greater than 20mm by conventional techniques or 10mm by spiral CT) OR elevated CA-125 (> 100 on two occasions at least one week apart performance status greater than or equal to 70% Exclusion Criteria: prior treatment with anti-angiogenesis agent treatment with > 2 cytotoxic regimens (including primary platinum and taxane chemotherapy) evidence of other malignancy within 3 years of study enrollment history of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation history of intra-abdominal abscess with 6 months prior to day 0 pregnant or lactating patients
Sites / Locations
- Virginia Mason Medical Center
- Puget Sound Oncology Consortium (PSOC)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Subjects received standard topotecan with the addition of bevacizumab. Cycles were 28 days and continued until toxicity, progression or subject wish to discontinue treatment. Topotecan administered 4 mg/m2 IV on days 1, 8 and 15 and bevacizumab IV 10 mg/kg, days 1 and 15 of each cycle.
Outcomes
Primary Outcome Measures
Progression Free Survival
Progression free survival(PFS)was measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with measurable disease. For patients with nonmeasurable disease, cancer antigen (CA-125) levels were used to determine response according to Rustin criteria. Progression-free survival was defined as number of months after beginning study treatment until progressive disease or death, respectively.
Secondary Outcome Measures
Evaluation of Overall Survival
Overall survival was defined as the number of months after commencing study treatment to death.
Objective Response Rate
RECIST criteria
Number or Participants With Toxicity
Full Information
NCT ID
NCT00343044
First Posted
June 20, 2006
Last Updated
April 29, 2015
Sponsor
Benaroya Research Institute
Collaborators
GlaxoSmithKline, Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00343044
Brief Title
Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers
Official Title
Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benaroya Research Institute
Collaborators
GlaxoSmithKline, Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the clinical safety and toxicity of intravenous bevacizumab (Days 1 and 15 of a 28 day cycle) in combination with weekly topotecan (Days 1, 8, 15 of a 28 day cycle) in patients with platinum resistant recurrent ovarian, fallopian tube and primary peritoneal cancer.
Detailed Description
This study is designed as a Phase 2 study. There are no published data on the toxicity of the combination of bevacizumab and topotecan therapy. Based on data combining bevacizumab with other chemotherapy agents in non-gynecologic solid tumors, it is not likely that the toxicity of the combination of the two drugs will be greater than the individual toxicities of each drug. The toxicities of each of these agents is quite different. Specifically the toxicity of this combination will be studied using the dose of bevacizumab used in previous phase II studies of ovarian cancer, e.g. an equivalent of 5 mg/kg weekly with treatments given at least every 3 weeks. In our study, since topotecan will be given weeks 1,2 and 3 of an every 4 week cycle, it is convenient to give bevacizumab 10 mg/kg IV every other week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Keywords
platinum resistant ovarian cancer, recurrent ovarian cancer, platinum resistant cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects received standard topotecan with the addition of bevacizumab. Cycles were 28 days and continued until toxicity, progression or subject wish to discontinue treatment. Topotecan administered 4 mg/m2 IV on days 1, 8 and 15 and bevacizumab IV 10 mg/kg, days 1 and 15 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Topotecan
Other Intervention Name(s)
Hycamtin
Intervention Description
Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Progression free survival(PFS)was measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with measurable disease. For patients with nonmeasurable disease, cancer antigen (CA-125) levels were used to determine response according to Rustin criteria. Progression-free survival was defined as number of months after beginning study treatment until progressive disease or death, respectively.
Time Frame
PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.
Secondary Outcome Measure Information:
Title
Evaluation of Overall Survival
Description
Overall survival was defined as the number of months after commencing study treatment to death.
Time Frame
PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.
Title
Objective Response Rate
Description
RECIST criteria
Time Frame
Response
Title
Number or Participants With Toxicity
Time Frame
measured at each treatment cycle
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
must have received primary taxane and platinum-based chemotherapy and no more than 1 other chemotherapy regimen
must have platinum resistant disease(defined as recurrence within 6 months of receiving platinum based chemotherapy, first or second line)
must have measurable disease (greater than 20mm by conventional techniques or 10mm by spiral CT) OR elevated CA-125 (> 100 on two occasions at least one week apart
performance status greater than or equal to 70%
Exclusion Criteria:
prior treatment with anti-angiogenesis agent
treatment with > 2 cytotoxic regimens (including primary platinum and taxane chemotherapy)
evidence of other malignancy within 3 years of study enrollment
history of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation
history of intra-abdominal abscess with 6 months prior to day 0
pregnant or lactating patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn McGonigle, MD
Organizational Affiliation
Virginia Mason Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Puget Sound Oncology Consortium (PSOC)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21815133
Citation
McGonigle KF, Muntz HG, Vuky J, Paley PJ, Veljovich DS, Greer BE, Goff BA, Gray HJ, Malpass TW. Combined weekly topotecan and biweekly bevacizumab in women with platinum-resistant ovarian, peritoneal, or fallopian tube cancer: results of a phase 2 study. Cancer. 2011 Aug 15;117(16):3731-40. doi: 10.1002/cncr.25967. Epub 2011 Feb 24.
Results Reference
result
Links:
URL
http://www.benaroyaresearch.org
Description
Benaroya Research Institute's homepage with listings of clinical trials
Learn more about this trial
Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers
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