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Single Agent Erlotinib in Chemotherapy-naive Androgen Independent Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier:
NCT00272038
First received: January 3, 2006
Last updated: August 12, 2013
Last verified: August 2013
Results First Received: May 6, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: Tarceva

  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
Eligible patients were those who met the criteria of Castration Resistant Prostate Cancer (CRPC)who had not yet received chemotherapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients must have had adquate bone marrow function and, Eastern Cooperative Oncology Group (ECOG) <3, and measurable disease.

Reporting Groups
  Description
Tarceva Tarceva 150 mg orally every day

Participant Flow:   Overall Study
    Tarceva  
STARTED     29  
COMPLETED     22  
NOT COMPLETED     7  
withdrew before they received 2 cycles                 7  



  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
Tarceva Tarceva 150 mg QD

Baseline Measures
    Tarceva  
Number of Participants  
[units: participants]
  29  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     27  
Gender  
[units: participants]
 
Female     0  
Male     29  
Region of Enrollment  
[units: participants]
 
United States     29  



  Outcome Measures
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1.  Primary:   Overall Clinical Benefit of Tarceva in CRPC.   [ Time Frame: 5 years ]

2.  Secondary:   Time to Disease Progression (TTP)   [ Time Frame: five years ]

3.  Secondary:   Overall Survival   [ Time Frame: during study ]

4.  Secondary:   Toxicity   [ Time Frame: during study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sigrun Hallmeyer, MD (Director of Research); Chadi Nabhan, MD, FACP (PI)
Organization: Oncology Specialists, S.C.
phone: 847-268-8200
e-mail: shallmeyer@oncmed.net


No publications provided by Oncology Specialists, S.C.

Publications automatically indexed to this study:

Responsible Party: Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier: NCT00272038     History of Changes
Obsolete Identifiers: NCT00321841
Other Study ID Numbers: OSI3652S (0513)
Study First Received: January 3, 2006
Results First Received: May 6, 2013
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board