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Single Agent Erlotinib in Chemotherapy-naive Androgen Independent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00272038
Recruitment Status : Completed
First Posted : January 4, 2006
Results First Posted : October 17, 2013
Last Update Posted : March 5, 2018
Sponsor:
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
  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

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
Tarceva Tarceva 150 mg QD

Baseline Measures
   Tarceva 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[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
No text entered.


  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
e-mail: shallmeyer@oncmed.net


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

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)
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