Text Size

A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma

This study has been terminated.
(Too slow accrual)
Sponsor:
Collaborators:
Genentech
Eli Lilly and Company
Information provided by (Responsible Party):
Walter Stadler, University of Chicago
ClinicalTrials.gov Identifier:
NCT00523640
First received: August 30, 2007
Last updated: November 18, 2011
Last verified: November 2011
History of Changes
Results First Received: August 15, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Renal Cell
Intervention: Drug: combination of gemcitabine, capecitabine, and bevacizumab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
30 patients were enrolled in the trial between March 2005 and May 2008

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
Combination of Gemcitabine, Capecitabine, and Bevacizumab combination of gemcitabine, capecitabine, and bevacizumab

Participant Flow:   Overall Study
    Combination of Gemcitabine, Capecitabine, and Bevacizumab  
STARTED     30  
COMPLETED     29 [1]
NOT COMPLETED     1  
Death                 1  
[1] 1 patient died before starting treatment



  Baseline Characteristics
  Show Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate   [ Time Frame: 12 weeks ]
  Show Outcome Measure 1

2.  Primary:   Progression-free Survival   [ Time Frame: 60 months ]
  Show Outcome Measure 2

3.  Secondary:   Overall Survival   [ Time Frame: 60 months ]
  Show Outcome Measure 3


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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


Limitations and Caveats
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
Trial was designed with a maximum target accrual of 55 patients. The trial was halted early because emerging data with VEGF inhibitors challenged clinical relevance of the study and availability of multiple therapies challenged accrual.  


Results Point of Contact:  
Name/Title: Theodore Karrison, PhD
Organization: University of Chicago
phone: 773-702-9326
e-mail: tkarrison@health.bsd.uchicago.edu


No publications provided


Responsible Party: Walter Stadler, University of Chicago
ClinicalTrials.gov Identifier: NCT00523640     History of Changes
Other Study ID Numbers: 13662A
Study First Received: August 30, 2007
Results First Received: August 15, 2011
Last Updated: November 18, 2011
Health Authority: United States: Food and Drug Administration