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

Alternate Title

Phase II Study of DJ-927 as Second-Line Treatment in Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Pharmaceutical / Industry	DAIICHI-927A-PRT004 MDA-2003-0749, NCT00080834

Trial Description

Purpose:

Drugs used in chemotherapy, such as DJ-927, work in different ways to stop tumor cells from dividing so they stop growing or die.

This phase II trial is studying how well DJ-927 works as second-line therapy in treating patients with progressive locally advanced or metastatic colorectal adenocarcinoma (cancer).

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Received one previous chemotherapy regimen that included irinotecan or oxaliplatin
• Measurable disease
• At least 4 weeks since radiation therapy or surgery
• No previous surgery to the stomach or small intestine
• 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 receive DJ-927 by mouth every 3 weeks. Treatment may continue for as long as benefit is shown. Patients will be evaluated every 3 months.

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

Daiichi Sankyo, Incorporated

Peter Cheverton, MD, ChB, MMED, RadT, Protocol chair		Ph: 44-171-936-2850

Registry Information
Official Title		A Phase II Study Of Oral DJ-927 Administered As A Single Dose Every Three Weeks To Patients With Advanced Or Metastatic Adenocarcinoma Of The Colon Or Rectum
Trial Start Date		2004-02-10
Registered in ClinicalTrials.gov		NCT00080834
Date Submitted to PDQ		2004-02-10
Information Last Verified		2005-04-29

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