Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy

Summary

Prostate cancer is prevalent in the United States, with approximately 230,110 new cases and 29,900 deaths in 2004. Approximately 30% of new cases will be clinical stage T3 when they are diagnosed. This is a stage in which there is high probability that the cancer has spread beyond the prostate gland itself, making it much more difficult to treat. In these cases, when surgery is done by itself and the prostate is removed, it is still very likely that some cancer that has spread beyond the prostate remains and will get worse. Radiation applied to the prostate also does not work well on tumors that have spread beyond the prostate. Even surgery and radiation combined have not eliminated the problems caused by prostate cancer that has spread into the tissue outside the prostate itself.

New treatments are needed to deal with prostate cancer at this more serious stage. Study doctors believe that it might be possible to shrink the prostate cancer using a new drug called SUO11248 or Sunitinib. After the patients take the drug, study doctors believe the cancer will shrink back to within the prostate, and they can then surgically remove the prostate and all the cancer. Patients on this study also will be given increasing doses of Sunitinib to find out how much of the drug can be given safely.

Conditions

• Prostate Cancer

Interventions

DRUG

SU011248

5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks.

DRUG

SU011248

5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks.

DRUG

SU011248

5 Subjects will receive 50.0 mg/d of the study drug for 1 week.

DRUG

SU011248

5 Subjects will receive 37.5 mg/d of the study drug for 1 week.

DRUG

SU011248

5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Arie Belldegrun, M.D. · University of California, Los Angeles

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-06-30

Primary Completion

2009-07-31

Countries

• United States

Study Locations