Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: docetaxel; Drug: estramustine phosphate sodium; Drug: exisulind

• Registration Number: NCT00052845
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Estramustine may fight prostate cancer by reducing the production of androgens. Exisulind may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining these therapies may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining estramustine with exisulind and docetaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Detailed Description

OBJECTIVES:

* Determine the time to objective and biochemical progression and response proportion (objective and post-therapy changes in PSA) in patients with hormone refractory metastatic prostate cancer treated with docetaxel, estramustine, and exisulind.

* Determine the toxic effects of this regimen in these patients.

* Determine the overall survival of patients treated with this regimen.

OUTLINE: Patients receive oral estramustine 3 times daily on days 1-5, docetaxel IV over 1 hour on day 2, and oral exisulind twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years.

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2003-01-24
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-01
• Study Completion: 2009-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-30
• Last Update Posted: 2016-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined chemotherapy	exisulind	combination of 3 chemotherapy agents for hormone refractory prostate cancer
Combined chemotherapy	estramustine phosphate sodium	combination of 3 chemotherapy agents for hormone refractory prostate cancer
Combined chemotherapy	docetaxel	combination of 3 chemotherapy agents for hormone refractory prostate cancer

Primary Outcome Measures

Name	Time	Method
Time to progression	24 months from study entry

Secondary Outcome Measures

Name	Time	Method
Changes in PSA	During treatment then q 3 mon until ds progression
Overall Survival	24 months from study entry
Toxicity	treatment up to 3 mon post treatment

Trial Locations

Locations (80)

Northeast Alabama Regional Medical Center; 🇺🇸 Anniston, Alabama, United States

Rebecca and John Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Veterans Affairs Medical Center - San Diego; 🇺🇸 San Diego, California, United States

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Veterans Affairs Medical Center - San Francisco; 🇺🇸 San Francisco, California, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

Lombardi Cancer Center of Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

Veterans Affairs Medical Center - Washington, DC; 🇺🇸 Washington, District of Columbia, United States

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