Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy (NRR)
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|ClinicalTrials.gov Identifier: NCT00246753|
Recruitment Status : Completed
First Posted : October 31, 2005
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with prostate cancer that did not respond to hormone therapy.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: lapatinib ditosylate||Phase 2|
- Determine the proportion of patients with hormone-refractory prostate cancer who experience > 50% decline in prostate-specific antigen (PSA) after treatment with lapatinib ditosylate.
- Determine the safety of this drug in these patients.
- Determine the time to PSA progression in patients treated with this drug.
- Determine the molecular correlates and predictive biomarkers of response in patients treated with this drug.
OUTLINE: This is a multicenter, open-label study.
Patients receive oral lapatinib ditosylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Serum samples are collected for biomarker analysis at baseline and every 4 weeks.
After completion of study treatment, patients are followed at 4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||May 2013|
Single Arm Trial
Single Arm Trial where each patient receives GW572016 (lapatinib ditosylate) at a dose of 1500mg daily initially until disease progression or unacceptable toxicity.
Drug: lapatinib ditosylate
1500 mg, daily until disease progression
Other Name: GW572016
- Number of Patients Experiencing Decline in Prostate-specific Antigen [ Time Frame: 4 years ]Determine the number of patients with hormone-refractory prostate cancer who experience > 50% decline in PSA from baseline for 2 successive measurements at least 4 weeks apart after treatment with lapatinib ditosylate.
- Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: 4 years ]Measured from start date of treatment to date of PSA progression, defined as a 25% increase above the pretreatment value or the nadir PSA (whichever is lower) and a minimum increase of 5 ng/ml, confirmed 2 or more weeks later.
- Predictive Molecular Markers of Response to Treatment With Lapatinib (GW572016) [ Time Frame: 4 years ]To assess the correlation between expression of molecular markers and patient response to treatment with GW572016
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246753
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Rex Cancer Center at Rex Hospital|
|Raleigh, North Carolina, United States, 27607|
|Principal Investigator:||Young Whang, MD, PhD||UNC Lineberger Comprehensive Cancer Center|