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Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

NCT00016913 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-07-06

Study results available
· View outcomes & findings →

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin or leuprolide may stop the adrenal glands from producing androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, hormone therapy, and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying giving chemotherapy together with hormone therapy and radiation therapy in treating patients with locally advanced prostate cancer.

Conditions

Interventions

DRUG

carboplatin

AUC=6 week one of each 4 week cycle

DRUG

estramustine

2 tablets tid PO 5 of 7 days per week each 4 week cycle

DRUG

paclitaxel

80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle

RADIATION

radiation therapy

77.4 Gy in 1.8 Gy fractions

DRUG

leuprolide or goserelin acetate

7.5 mg IM injection once every 4 weeks for 6 months

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • William K. Kelly, DO · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2007-07-31
Completion
2008-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00016913 on ClinicalTrials.gov