Single Agent Erlotinib in Chemotherapy-naive Androgen Independent Prostate Cancer

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. Identifier: NCT00272038
Recruitment Status : Completed
First Posted : January 4, 2006
Results First Posted : October 17, 2013
Last Update Posted : March 5, 2018
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: Tarceva

  Participant Flow

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
Tarceva Tarceva 150 mg orally every day

Participant Flow:   Overall Study
withdrew before they received 2 cycles                7 

  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.
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Reporting Groups
Tarceva Tarceva 150 mg QD

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      2   6.9% 
>=65 years      27  93.1% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      0   0.0% 
Male      29 100.0% 
Region of Enrollment 
[Units: Participants]
United States   29 

  Outcome Measures

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

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

  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
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  More Information

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Dr. Sigrun Hallmeyer, Oncology Specialists, S.C. Identifier: NCT00272038     History of Changes
Obsolete Identifiers: NCT00321841
Other Study ID Numbers: OSI3652S (0513)
First Submitted: January 3, 2006
First Posted: January 4, 2006
Results First Submitted: May 6, 2013
Results First Posted: October 17, 2013
Last Update Posted: March 5, 2018