SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
NCT00026377 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2013-09-05
Summary
RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, bicalutamide, leuprolide, or goserelin may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining SU5416, hormone therapy, and radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of SU5416 plus hormone therapy and radiation therapy in treating patients who have prostate cancer.
Conditions
Interventions
- DRUG
-
bicalutamide
50 mg daily for 1 month
- DRUG
-
flutamide
250 mg 3 times daily for 1 month
- DRUG
-
goserelin acetate
3.6 mg once a month for 4 months
- DRUG
-
leuprolide acetate
7.5 mg once a month for 4 months
- DRUG
-
SU5416
IV infusion at assigned dose
- RADIATION
-
radiation therapy
daily for 5 days each week
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of Chicago
lead OTHER
Principal Investigators
-
Walter M. Stadler, MD, FACP · University of Chicago
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-11-30
- Primary Completion
- 2002-03-31
- Completion
- 2003-04-30
Countries
- United States
Study Locations
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