Protocol Number: 04-C-0262

Title:

A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer

Number:

04-C-0262

Summary:

BAY 43-9006 is an experimental cancer drug produced by Bayer Health Care Corporation. It represents a new class of anticancer agents known as bi-aryl ureas. This study will investigate its effect on prostate cancer and its side effects. Researchers expect to enroll a maximum of 46 men with prostate cancer for this study. The duration of the study will depend on its results.

Before beginning to take the drug, patients will be admitted to the hospital for 2 days, have a medical examination and give blood samples, and have a tumor or bone marrow biopsy. On the first day of the study, patients will begin taking the drug as 2 tablets twice daily, morning and evening. Blood will be taken throughout the day to determine the drug's level in the bloodstream.

Patients will be discharged from the hospital on the second day, and will continue to take the drug twice daily until instructed to stop. During each of the first 4 weeks, patients will be required to have their blood pressure checked. At the end of the first 4 weeks, patients will have a physical examination and blood tests, as well as a second tumor or bone marrow biopsy.

After the first 4 weeks, patients will continue with their drug regimen. At the end of each 4-week cycle, patients will have a physical examination and blood tests. Patients will also have x-Rays, CT scans, and/or MRIs at every other 4-week examination or as required. Patients will be asked to keep a diary recording the time and amount of their medication for this study.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male

Referral Letter Required: No

Population Exclusion(s): Female

Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Hormone-Refractory

Proteomics

Angiogenesis

VEGFR

Recruitment Keyword(s):

Prostate Cancer

Metastatic Prostate Cancer

Condition(s):

Prostate Cancer

Investigational Drug(s):

BAY 43-9006

Investigational Device(s):

None

Interventions:

Drug: BAY 43-9006

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Jemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003.CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26.

Rini BI, Small EJ. Prostate cancer update.Curr Opin Oncol. 2002 May;14(3):286-91. Review.

Klotz L. Hormone therapy for patients with prostate carcinoma. Cancer. 2000 Jun 15;88(12 Suppl):3009-14. Review.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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