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Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer

NCT00024167 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2016-03-22

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radioactive substances such as strontium-89 may relieve bone pain associated with prostate cancer. It is not yet known whether chemotherapy is more effective with or without strontium-89 in treating bone metastases.

PURPOSE: This randomized phase III trial is studying giving chemotherapy together with strontium-89 to see how well it works compared to chemotherapy alone in treating patients with prostate cancer that has spread to the bone.

Conditions

Interventions

DRUG

Docetaxel

75 mg/m2 intravenous piggyback (IVPB) over 1 hour, Day 1, every 3 weeks.

DRUG

Doxorubicin hydrochloride

20 mg/m2 IV, day 1 on Weeks 1, 3, 5

DRUG

Estramustine phosphate sodium

140 mg orally 3 x day, Days 1 through 7 on Weeks 2, 4, 6

DRUG

Ketoconazole

400 mg orally (po) 3 x day, Days 1 through 7

DRUG

Prednisone

5 mg orally 2 x daily, weeks 1-14

DRUG

Vinblastine

4 mg/m2 IVPB, Day 1 on Weeks 2, 4, 6

RADIATION

Strontium chloride Sr 89

One dose (4 mCi total dose) IV

DRUG

Dexamethasone

4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Shi-Ming Tu, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2014-09-30

Countries

  • United States

Study Locations

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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 NCT00024167 on ClinicalTrials.gov