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Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00782275
Recruitment Status : Completed
First Posted : October 31, 2008
Results First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Renal Cell Carcinoma
Kidney Cancer
Interventions: Drug: bevacizumab
Drug: temsirolimus

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled between April 2009 and May 2013.

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 + Temsirolimus

bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15)

temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22

1 cycle=28 days

There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression.


Participant Flow:   Overall Study
    Bevacizumab + Temsirolimus
STARTED   41 
Treated   40 
Prior VEGFR Response Evaluable [1]   39 [2] 
COMPLETED   0 [3] 
NOT COMPLETED   41 
Adverse Event                11 
Withdrawal by Subject                1 
Progressive Disease                21 
Physician Decision                4 
Not started treatment                1 
Other                3 
[1] Pts were classified by response to previous VEGFR TKI therapy at baseline: refractory or responsive.
[2] One patient was unevaluable and therefore excluded from related subgroup analyses.
[3] Since treatment duration was not fixed, patients were not considered to have completed treatment.



  Baseline Characteristics

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.
The analysis dataset is comprised of all treated patients as opposed to enrolled patients.

Reporting Groups
  Description
Bevacizumab + Temsirolimus

bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15)

temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22

1 cycle=28 days

There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression.


Baseline Measures
   Bevacizumab + Temsirolimus 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Years]
Median (Full Range)
 60 
 (32 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  17.5% 
Male      33  82.5% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   40 
Primary VEGF Refractory Status [1] [2] 
[Units: Participants]
Count of Participants
 
VEGF Refractory-No   20 
VEGF Refractory-Yes   19 
Unevaluable   1 
[1] Primary VEGF refractory status was based on the prior therapy form; patients were considered refractory if response on prior therapy was progressive disease OR prior therapy duration was < 3 months and patient experienced progression at the end of therapy.
[2] One patient did not have enough data to determine VEGF-refractory status.
MSKCC Risk Category [1] 
[Units: Participants]
Count of Participants
 
Favorable      5  12.5% 
Intermediate      31  77.5% 
Poor      4  10.0% 
[1] The Memorial Sloan Kettering Cancer Center (MSKCC) risk score is based on the sum of positive answers to the following criteria: 1) time from the earliest of initial or metastatic diagnosis to first prior treatment < 1 year; 2) Karnofsky Performance Score < 80%; 3) HgB < LLN; 4) Corrected Calcium > 10 mg/dL; and 5) NLDH> 1.5xULN. Patients were further classified into risk groups based on the score of 0=Favorable, 1-2=Intermediate and 3-5=Poor Risk. (Motzer et al. Cancer 2008; 113)


  Outcome Measures

1.  Primary:   4-month Progression-Free Survival Rate   [ Time Frame: Disease evaluations occurred every 8 weeks (+/- 1 wk) on treatment. Relevant for this endpoint was disease status at 4 months. ]

2.  Secondary:   Objective Response Rate   [ Time Frame: Disease evaluations occurred every 8 weeks (+/- 1 wk) on treatment; Treatment continued until disease progression or unacceptable toxicity. Median (range) of treatment duration for this study cohort was 5 cycles (1-39) [1 cycle=28days]. ]

3.  Secondary:   Overall Survival   [ Time Frame: Median follow-up for survival in this study cohort is 56 months. ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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: David F. McDermott MD PhD
Organization: Beth Israel Deaconess Medical Center
phone: 617-632-9262
e-mail: dmcdermo@bidmc.harvard.edu


Publications of Results:

Responsible Party: David F. McDermott, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00782275     History of Changes
Other Study ID Numbers: 08-184
First Submitted: October 29, 2008
First Posted: October 31, 2008
Results First Submitted: February 1, 2017
Results First Posted: December 20, 2017
Last Update Posted: December 20, 2017