Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Dror Michaelson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00556049
First received: November 7, 2007
Last updated: March 24, 2015
Last verified: March 2015
Results First Received: March 24, 2015  
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: Renal Cell Carcinoma
Neoplasm Metastases
Interventions: Drug: Gemcitabine
Drug: Sunitinib

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment

Sunitinib and gemcitabine

Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.

Sunitinib: Orally on days 1-14 of each 21-day treatment cycle


Participant Flow:   Overall Study
    Treatment  
STARTED     72  
COMPLETED     72  
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.
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Reporting Groups
  Description
Treatment

Sunitinib and gemcitabine

Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.

Sunitinib: Orally on days 1-14 of each 21-day treatment cycle


Baseline Measures
    Treatment  
Number of Participants  
[units: participants]
  72  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     60  
>=65 years     12  
Age  
[units: years]
Median (Full Range)
  58    (45 to 75)  
Gender  
[units: participants]
 
Female     30  
Male     42  
Region of Enrollment  
[units: participants]
 
United States     72  



  Outcome Measures

1.  Primary:   To Determine the Overall Response Rate of Combination Therapy With Gemcitabine and Sunitinib in Sarcomatoid and/or Poor-risk mRCC Patients as First Line Therapy.   [ Time Frame: Until disease progression ]


  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: Dr. M. Dror Michaelson
Organization: MGH Cancer Center
phone: 617-726-1594
e-mail: dmichaelson1@partners.org


No publications provided


Responsible Party: Dror Michaelson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00556049     History of Changes
Other Study ID Numbers: 07-212
Study First Received: November 7, 2007
Results First Received: March 24, 2015
Last Updated: March 24, 2015
Health Authority: United States: Institutional Review Board