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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 I/II Study of Bortezomib Alone or With Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (EPOCH) in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	NCI	NCI-03-C-0096 NCI-5748, 5748, NCT00057902

Special Category: NCI Web site featured trial

Trial Description

Purpose:

Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining bortezomib with combination chemotherapy may kill more cancer cells.

This phase I/II trial is studying the side effects and best dose of bortezomib when given together with combination chemotherapy and to see how well they work compared to bortezomib alone in treating patients with relapsed or refractory large B-cell lymphoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• More than 4 weeks since anticancer therapy
• 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:

Some patients will receive an infusion of bortezomib on days 1, 4, 8, and 11. Treatment may be repeated every 3 weeks for about 5 months. Patients may then:

• Continue treatment with bortezomib for up to 1 year; or
• Undergo autologous or allogeneic stem cell transplantation; or
• Receive treatment with combination chemotherapy and bortezomib as described below.

Other patients will receive a 4-day continuous infusion of etoposide, doxorubicin, and vincristine, an infusion of cyclophosphamide on day 5, and prednisone by mouth twice a day for 5 days. They will also receive an infusion of bortezomib on days 1 and 4, and injections of filgrastim beginning on day 6 and continuing until blood counts return to normal. Treatment may be repeated every 3 weeks for up to six courses.

Patients will be evaluated every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and once a year thereafter.

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

NCI - Center for Cancer Research

Louis Staudt, MD, Protocol chair		Ph: 301-402-1892
Wyndham Wilson, MD, PhD, Principal investigator		Ph: 301-435-2415

Related Information

Featured trial article

Registry Information
Official Title		PS-341 and PS-341 + EPOCH Chemotherapy and Molecular Profiling in Relapsed or Refractory Diffuse Large B-Cell Lymphomas
Trial Start Date		2003-02-05
Trial Completion Date		2008-11-24
Registered in ClinicalTrials.gov		NCT00057902
Date Submitted to PDQ		2003-02-04
Information Last Verified		2007-01-07

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