Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent 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.|
|ClinicalTrials.gov Identifier: NCT00103194|
Recruitment Status : Completed
First Posted : February 8, 2005
Results First Posted : April 13, 2012
Last Update Posted : September 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer||Drug: lapatinib ditosylate Other: laboratory biomarker analysis||Phase 2|
I. To evaluate the percentage of patients with hormone sensitive prostate cancer who experience > 50% decline in serum PSA during treatment with GW572016 (lapatinib ditosylate).
I. To evaluate the duration of PSA decline. II. To characterize the change in PSA slope with GW572016. III. To characterize the safety and tolerability of GW572016 in this patient population.
IV. To estimate the time to progression (TTP) and progression-free survival at 2 years (from start of therapy).
V. To evaluate the correlation of epidermal growth factor receptor (EGFR) expression/signaling (from available prostate biopsy specimens or prostatectomy blocks) and its relationship to change in PSA in patients treated with GW572016.
Patients receive lapatinib ditosylate orally (PO) daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, or every year if patient is 5-10 years from study entry for 10 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident by a Rising PSA|
|Study Start Date :||September 2005|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
Experimental: Treatment (lapatinib ditosylate)
Patients receive lapatinib ditosylate PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: lapatinib ditosylate
Other Names:Other: laboratory biomarker analysis
- 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 ]
PSA response is defined as either complete response (CR) or partial response (PR) observed at any time during the entire measurement time period.
CR: In patients treated with prior radical prostatectomy, a PSA < 0.2 ng/mL confirmed by a repeat PSA at least one month apart was considered a complete biochemical response. In patients treated with radiation therapy only, a PSA < 1 ng/mL on three separate occasions taken at least one month apart was considered a complete biochemical response.
PR: A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later.
- 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 ]PSA was evaluated every cycle while on treatment. PSA test results show the level of PSA detected in the blood. These results were reported as nanograms of PSA per milliliter (ng/mL) of blood. PSA slope is the change in PSA level over time. A sharp rise in the PSA level raises the suspicion of cancer and may indicate a fast-growing cancer.
- 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 ]Proportion of patients who are living with a disease that does not get worse at 2 years from registration based on Kaplan-Meier method.
- 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 ]The association between EGFR (epidermal growth factor receptor) expression levels and the length of time during and after treatment in which a patient is living with a disease that does not get worse.
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): NCT00103194
|United States, Pennsylvania|
|ECOG-ACRIN Cancer Research Group|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||Glenn Liu||ECOG-ACRIN Cancer Research Group|