Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00103194
First received: February 7, 2005
Last updated: June 27, 2014
Last verified: June 2014
Results First Received: November 3, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Interventions: Drug: lapatinib ditosylate
Other: laboratory biomarker analysis

  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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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
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 ]

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 ]

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 ]

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 ]


  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
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00103194     History of Changes
Obsolete Identifiers: NCT02154373
Other Study ID Numbers: NCI-2014-01158, NCI-2014-01158, ECOG-E5803, CDR0000409729, E5803, E5803, U10CA180820, U10CA021115
Study First Received: February 7, 2005
Results First Received: November 3, 2011
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration