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GW572016 (Lapatinib) in Treating Patients With Recurrent Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00103194
First received: February 7, 2005
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
Results First Received: November 3, 2011  
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: GW572016 (lapatinib)

  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
Participants were recruited from ECOG member institutions between September 29, 2005 and July 5, 2006.

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
GW572016 (Lapatinib) GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.

Participant Flow:   Overall Study
    GW572016 (Lapatinib)  
STARTED     49  
Treated     49  
Eligible     35  
Eligible and Treated     35  
COMPLETED     18  
NOT COMPLETED     31  



  Baseline Characteristics
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Reporting Groups
  Description
GW572016 (Lapatinib) GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.

Baseline Measures
    GW572016 (Lapatinib)  
Number of Participants  
[units: participants]
 		  35  
Age [1]
[units: years]
Median ( Full Range ) 		  65  
  ( 48 to 81 )  
Gender [2]
[units: participants]
 		 
Female     0  
Male     35  
[1] Age of eligible patients who began treatment.
[2] Gender of eligible patients who began treatment.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level   [ Time Frame: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years ]
  Show Outcome Measure 1

2.  Secondary:   The Change in PSA Slope With GW572016 (Lapatinib)   [ Time Frame: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually, for 5 years ]
  Show Outcome Measure 2

3.  Secondary:   Progression-free Survival Rate at 2 Years   [ Time Frame: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years ]
  Show Outcome Measure 3

4.  Secondary:   Relationship Between Progression-free Survival and EGFR Expression Levels   [ Time Frame: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years ]
  Show Outcome Measure 4


  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
No text entered.  


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


Publications of Results:
Liu G, Chen Y, Pins M, et al.: E5803: A phase II trial of lapatinib (GW572016) in patients with recurrent prostate cancer as evident by a rising PSA. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-169, 2008.


Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00103194     History of Changes
Other Study ID Numbers: CDR0000409729, U10CA021115, ECOG-E5803
Study First Received: February 7, 2005
Results First Received: November 3, 2011
Last Updated: April 12, 2012
Health Authority: United States: Federal Government