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Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00068393
First received: September 10, 2003
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
Results First Received: November 30, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Metastatic Renal Cell Carcinoma
Renal Cell Carcinoma With Sarcomatoid Features
Interventions: Drug: Doxorubicin
Drug: Gemcitabine
Drug: G-CSF (granulocyte-colony stimulating factor)
Drug: Neulasta

  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
The study was activated on December 9, 2003 and was closed to accrual on April 19, 2007. A total of 39 patients were registered to the study.

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
Doxorubicin/Gemcitabine

Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.

Only eligible and treated patients are included in the analysis.

Participant Flow:   Overall Study
    Doxorubicin/Gemcitabine  
STARTED     39  
Eligible and Treated     38  
COMPLETED     29  
NOT COMPLETED     10  
Adverse Event                 2  
Death                 3  
Withdrawal by Subject                 3  
Alternative treatment                 1  
Quality of life worsening                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Doxorubicin/Gemcitabine

Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.

Only eligible and treated patients are included in the analysis.

Baseline Measures
    Doxorubicin/Gemcitabine  
Number of Participants  
[units: participants]
 		  38  
Age  
[units: years]
Median ( Full Range ) 		  59  
  ( 36 to 77 )  
Gender  
[units: participants]
 		 
Female     8  
Male     30  
Region of Enrollment  
[units: participants]
 		 
United States     38  



  Outcome Measures
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1.  Primary:   Response Rate by Solid Tumor Response Criteria (RECIST)   [ Time Frame: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry ]
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2.  Secondary:   Overall Survival   [ Time Frame: Every 2 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry ]
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3.  Secondary:   Progression-free Survival   [ Time Frame: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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
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Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


Publications of Results:
Haas N, Manola J, Pins M, et al.: ECOG 8802: phase II trial of doxorubicin (Dox) and gemcitabine (Gem) in metastatic renal cell carcinoma (RCC) with sarcomatoid features. [Abstract] J Clin Oncol 27 (Suppl 15): A-5038, 2009.


Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00068393     History of Changes
Other Study ID Numbers: CDR0000322258, E8802, U10CA021115
Study First Received: September 10, 2003
Results First Received: November 30, 2012
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration