Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT00103194
Status:
COMPLETED
Last Update Posted:
2014-09-30
First Post:
2005-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident by a Rising PSA
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well lapatinib ditosylate works in treating patients with a rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that prostate cancer has come back after previous treatment. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may delay or prevent the progression of prostate cancer.
Detailed Description:
PRIMARY OBJECTIVES:
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).
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
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).
SECONDARY OBJECTIVES:
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.
OUTLINE:
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-01158 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| E5803 | OTHER | Eastern Cooperative Oncology Group (ECOG) | View | |
| CDR0000409729 | None | None | View | |
| U10CA180820 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10CA021115 | NIH | None | https://reporter.nih.gov/quic… | View |