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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00026377 on ClinicalTrials.gov