Bevacizumab Study With Carboplatin & Paclitaxel in Ovarian, Fallopian Tube or Primary Peritoneal Cancer

This study has been terminated.
(Did not meet accrual goals.)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00408070
First received: December 5, 2006
Last updated: November 16, 2010
Last verified: November 2010
Results First Received: October 14, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Stage 3 Cancer
Stage 4 Cancer
Interventions: Drug: Bevacizumab
Drug: Carboplatin
Drug: Paclitaxel

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bevacizumab Plus Carboplatin and Paclitaxel This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles

Participant Flow:   Overall Study
    Bevacizumab Plus Carboplatin and Paclitaxel  
STARTED     5  
COMPLETED     5  
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
Bevacizumab Plus Carboplatin and Paclitaxel This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles

Baseline Measures
    Bevacizumab Plus Carboplatin and Paclitaxel  
Number of Participants  
[units: participants]
  5  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation
  62  ± 11.20  
Gender  
[units: participants]
 
Female     5  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     5  



  Outcome Measures

1.  Primary:   Progression Free Survival Rate at 9 Months   [ Time Frame: 9 months ]

2.  Secondary:   Response to Treatment (Clinical/Pathological)   [ Time Frame: not assessed; study terminated early ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Rate of Decline of CA-125   [ Time Frame: not assessed; study terminated early ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   To Determine the Degree and Type of Toxicity of This Combined Regimen   [ Time Frame: weekly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Determine Tolerability to 12 Months (q 3 Weeks) of Bevacizumab Maintenance Therapy   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
This trial ended early after enrolling only 5 of 100 patients. Due to the small enrollment number and incomplete data set, no data analyses were performed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Paige Dunion
Organization: UCHC
phone: 860-679-6571
e-mail: pdunion@uchc.edu


No publications provided


Responsible Party: Carolyn Runowicz, MD, Univ. of CT Health Center
ClinicalTrials.gov Identifier: NCT00408070     History of Changes
Other Study ID Numbers: AVF 3696s, IRB 06-337-1
Study First Received: December 5, 2006
Results First Received: October 14, 2010
Last Updated: November 16, 2010
Health Authority: United States: Food and Drug Administration