Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers
|ClinicalTrials.gov Identifier: NCT00343044|
Recruitment Status : Completed
First Posted : June 22, 2006
Results First Posted : May 15, 2015
Last Update Posted : May 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer||Drug: Topotecan Drug: Bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Weekly Topotecan With Bevacizumab in Platinum Resistant Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers|
|Study Start Date :||June 2006|
|Primary Completion Date :||January 2010|
|Study Completion Date :||August 2011|
U.S. FDA Resources
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.
Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV.
Other Name: HycamtinDrug: Bevacizumab
bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle.
Other Name: Avastin
- Progression Free Survival [ Time Frame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death. ]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.
- Evaluation of Overall Survival [ Time Frame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death. ]Overall survival was defined as the number of months after commencing study treatment to death.
- Objective Response Rate [ Time Frame: Response ]RECIST criteria
- Number or Participants With Toxicity [ Time Frame: measured at each treatment cycle ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343044
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|Puget Sound Oncology Consortium (PSOC)|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Kathryn McGonigle, MD||Virginia Mason Medical Center|