Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00103194
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date September 2005
Completion date June 2013

See also
  Status Clinical Trial Phase
Completed NCT02217709 - Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer Phase 2
Recruiting NCT03718260 - PSMA-PET Registry for Recurrent Prostate Cancer N/A
Active, not recruiting NCT01685125 - Abiraterone Acetate and Prednisone With or Without Dasatinib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 2
Completed NCT01054079 - Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer Phase 2
Terminated NCT00512668 - Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer Phase 1
Completed NCT00087139 - Ixabepilone in Treating Patients With Metastatic Prostate Cancer Phase 2
Recruiting NCT05304858 - Tumor Microenvironment Analysis of Prostate Cancer Metastasis
Completed NCT02250014 - The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer Phase 1
Active, not recruiting NCT01655836 - High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer Phase 1
Terminated NCT01866423 - Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 2
Not yet recruiting NCT06070272 - Determining Patterns In Trial Experiences of Recurrent Prostate Cancer Patients
Completed NCT01468532 - Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 1/Phase 2
Completed NCT01260688 - Cediranib Maleate With or Without Dasatinib in Patients With HRPC-Resistant to Treatment With Docetaxel Phase 2
Completed NCT01682941 - Soy Isoflavones in Treating Patients With Recurrent Prostate Cancer or Rising Prostate-Specific Antigen N/A
Completed NCT01220817 - Safety and Efficacy of POMx Capsules in Men With Recurrent Prostate Cancer: An 18-Month Study Phase 2
Completed NCT00775866 - MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy N/A
Completed NCT00074022 - GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors Phase 1/Phase 2
Recruiting NCT05044754 - SCAP vs HIFU for Recurrent Prostate Cancer After Radiation Therapy
Active, not recruiting NCT01923506 - Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery Phase 1
Completed NCT01808222 - FACBC for Recurrent Prostate Cancer Phase 2