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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase III Randomized Study of Docetaxel and Prednisone With Versus Without Bevacizumab in Patients With Hormone-Refractory Metastatic Adenocarcinoma of the Prostate

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	CALGB-90401 ECOG-90401, NCT00110214

Special Category: CTSU trial

Trial Description

Purpose:

Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether docetaxel, prednisone, and bevacizumab are more effective than docetaxel and prednisone in treating prostate cancer.

This randomized phase III trial is studying docetaxel, prednisone, and bevacizumab to see how well they work compared to docetaxel and prednisone in treating patients with prostate cancer that did not respond to hormone therapy.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No brain metastases
• At least 4 weeks since hormone therapy, radiation therapy, or surgery
• At least 8 weeks since strontium-89 or samarium-153
• No previous angiogenesis inhibitors, including thalidomide, bevacizumab, or suramin
• No previous chemotherapy, including estramustine
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive a 1-hour infusion of docetaxel and a 30- to 90-minute infusion of placebo once in week 1. They will also receive prednisone by mouth once a day for 3 weeks.

Patients in group two will receive docetaxel and prednisone as in group one. They will also receive a 30- to 90-minute infusion of bevacizumab once in week 1.

In both groups, treatment may repeat every 3 weeks for up to 2 years.

After finishing study treatment, patients will be evaluated periodically for up to 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

William Kelly, DO, Protocol chair		Ph: 203-737-2572

Eastern Cooperative Oncology Group

Michael Carducci, MD, Protocol chair		Ph: 410-614-3977 Email: carducci@welchlink.welch.jhu.edu

Related Information

PDQ® clinical trial CALGB-90202
Featured trial article

Registry Information
Official Title		A Randomized Double-Blinded Placebo Controlled Phase III Trial Comparing Docetaxel and Prednisone With and Without Bevacizumab (IND #7921, NSC #704865) In Men With Hormone Refratory Prostate Cancer
Trial Start Date		2005-04-15
Trial Completion Date		2007-12-21 (estimated)
Registered in ClinicalTrials.gov		NCT00110214
Date Submitted to PDQ		2005-03-23
Information Last Verified		2008-01-16
NCI Grant/Contract Number		CA31946

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