Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers
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|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|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||August 2011|
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: Hycamtin
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|