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Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00276549
First received: January 12, 2006
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
Results First Received: April 26, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: docetaxel
Drug: gemcitabine hydrochloride

  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
Patients were recruited from July 2004-October 2006 from medical clinic.

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
Gemcitabine (Gemzar) and Docetaxel (Taxotere) Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.

Participant Flow:   Overall Study
    Gemcitabine (Gemzar) and Docetaxel (Taxotere)  
STARTED     35  
COMPLETED     35  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Gemcitabine (Gemzar) and Docetaxel (Taxotere) Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.

Baseline Measures
    Gemcitabine (Gemzar) and Docetaxel (Taxotere)  
Number of Participants  
[units: participants]
 		  35  
Age  
[units: years]
Median ( Full Range ) 		  67  
  ( 55 to 84 )  
Gender  
[units: participants]
 		 
Female     0  
Male     35  
Region of Enrollment  
[units: participants]
 		 
United States     35  



  Outcome Measures
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1.  Primary:   Objective PSA Response Rate (Number of Patients With a PSA Response)   [ Time Frame: every 4 weeks ]
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2.  Primary:   Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).   [ Time Frame: at 4 weeks after treatment completion ]
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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:  
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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Robert Dreicer
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
phone: 216-445-4623
e-mail: dreicer@ccf.org


No publications provided


Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00276549     History of Changes
Other Study ID Numbers: CCF7143, P30CA043703, CASE-CCF-7143
Study First Received: January 12, 2006
Results First Received: April 26, 2012
Last Updated: January 24, 2013
Health Authority: United States: Federal Government