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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00103194 |
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 recurrent prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: lapatinib ditosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident By a Rising PSA |
Estimated Enrollment: | 50 |
Study Start Date: | September 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral lapatinib once 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 every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biochemical disease progression after prior definitive surgery or radiotherapy, as evidenced by all of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No unstable arrhythmias on ECG
Gastrointestinal
No GI tract disease resulting in either of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent CYP3A4 inducers or inhibitors
Study ID Numbers: | CDR0000409729, ECOG-E5803 |
Study First Received: | February 7, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00103194 |
Health Authority: | United States: Federal Government |
recurrent prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Lapatinib Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |