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CCI-779 and Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00112840
First received: June 2, 2005
Last updated: September 4, 2014
Last verified: January 2014
Results First Received: January 6, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions: Drug: CCI-779
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
From 5/11/2005 to 7/19/2006, 14 participants were registered to the Phase I portion of the study (8 at Dose Level 1 and 6 at Dose Level 2). Phase II opened 02/09/2007 at Dose Level 2 and registered 46 patients before closing with full accrual on 6/15/2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In Phase I, Dose Level 2, 2 subjects were unevaluable because they were removed from the study before completing cycle 1 of treatment for reasons other than toxicity. In Phase II, 5/46 patients were ineligible and one patient cancelled.

Reporting Groups
  Description
Phase I, Dose Level 1 Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase I, Dose Level 2 Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1= 10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.

Participant Flow:   Overall Study
    Phase I, Dose Level 1     Phase I, Dose Level 2     Phase II  
STARTED     8     6     46  
COMPLETED     6     6     40  
NOT COMPLETED     2     0     6  
Physician Decision                 1                 0                 0  
Withdrawal by Subject                 1                 0                 1  
Protocol Violation                 0                 0                 5  



  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
Phase I, Dose Level 1 Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase I, Dose Level 2 Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
Total Total of all reporting groups

Baseline Measures
    Phase I, Dose Level 1     Phase I, Dose Level 2     Phase II     Total  
Number of Participants  
[units: participants]
  8     6     46     60  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 44 to 75 )  
  66  
  ( 61 to 77 )  
  62  
  ( 38 to 82 )  
  62.5  
  ( 38 to 82 )  
Gender  
[units: participants]
       
Female     1     1     11     13  
Male     7     5     35     47  
Region of Enrollment  
[units: participants]
       
United States     8     6     46     60  



  Outcome Measures
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1.  Primary:   Dose-limiting Toxicity (DLT) (Phase I)   [ Time Frame: Patients observed a minimum of 4 weeks (one full course). The maximum number of cycles observed was 16 cycles. ]

2.  Primary:   Proportion of Progression-free Patients at 6 Months (Phase II)   [ Time Frame: 6 months after study entry ]

3.  Secondary:   Clinical Best Response Rate of CCI-779 and Bevacizumab in Patients With Metastatic Renal Cell (Phase II)   [ Time Frame: Up to 3 years from study registration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Time to Progression (Phase II)   [ Time Frame: Up to 3 years from study registration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Overall Survival (Phase I and II)   [ Time Frame: Up to 3 years from study registration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Time to Treatment Failure (Phase I and II)   [ Time Frame: Up to 3 years from study registration ]
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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jaime Merchan, M.D.
Organization: University of Miami – Sylvester Comprehensive Cancer Center
e-mail: jmerchan2@med.miami.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00112840     History of Changes
Other Study ID Numbers: NCI-2009-00109, NCI-2009-00109, CDR0000428311, NCI-6986, MC0452, 6986, N01CM62205
Study First Received: June 2, 2005
Results First Received: January 6, 2014
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration