Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Genentech, Inc.
Information provided by (Responsible Party):
Beth Edelheit, Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT00343044
First received: June 20, 2006
Last updated: April 29, 2015
Last verified: April 2015
Results First Received: July 29, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Interventions: Drug: Topotecan
Drug: Bevacizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects enrolled from August 2006 to November 2008, in the medical oncoogy practices at Virginia Mason Medical Center and the Puget Sound Oncology Consortium in Seattle, WA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Women had advanced or recurrent epithelial ovarian, peritoneal, or fallopian tube cancer. Enrollment was restricted to women who had received a maximum of two prior chemotherapy regimens, with at least one prior primary taxane and platinum-based therapy.

Reporting Groups
  Description
Combined Weekly Topotecan and Biweekly Bevacizumab Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.

Participant Flow:   Overall Study
    Combined Weekly Topotecan and Biweekly Bevacizumab  
STARTED     40  
COMPLETED     40  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Combined Weekly Topotecan and Biweekly Bevacizumab Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.

Baseline Measures
    Combined Weekly Topotecan and Biweekly Bevacizumab  
Number of Participants  
[units: participants]
  40  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     37  
>=65 years     3  
Age  
[units: years]
Mean (Standard Deviation)
  58.6  (11.31)  
Gender  
[units: participants]
 
Female     40  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     40  



  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death. ]

2.  Secondary:   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. ]

3.  Secondary:   Objective Response Rate   [ Time Frame: Response ]

4.  Secondary:   Number or Participants With Toxicity   [ Time Frame: measured at each treatment cycle ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Thomas Malpass, M.D., Principal Investigator
Organization: Benaroya Research Institute at Virginia Mason
phone: 206-223-6193
e-mail: thomas.malpass@vmmc.org


Publications of Results:

Responsible Party: Beth Edelheit, Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT00343044     History of Changes
Other Study ID Numbers: 3040200, AVF3648s
Study First Received: June 20, 2006
Results First Received: July 29, 2013
Last Updated: April 29, 2015
Health Authority: United States: Food and Drug Administration