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

Alternate Title

Phase I/II Study of Dose-Dense and Dose-Intense Capecitabine in Combination With Alternating Full-Dose Irinotecan Hydrochloride and Oxaliplatin With or Without Bevacizumab in Patients With Metastatic or Locally Advanced Unresectable Colorectal Cancer or Other Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	18 and over	NCI	CASE-1205 NCI-7325, 7325, NCT00296062

Special Category: NCI - CMS pilot project trial

Trial Description

Purpose:

Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also block blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

This phase I/II trial is studying the side effects and best dose of capecitabine when given together with irinotecan and oxaliplatin with or without bevacizumab and to see how well they work in treating patients with metastatic or locally advanced colorectal cancer or other solid tumors that cannot be removed by surgery.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable or evaluable disease
• No brain metastases
• At least 4 weeks since radiation 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:

Patients will receive capecitabine by mouth twice a day for 7 days. Treatment with capecitabine may repeat every other week for as long as benefit is shown. They will receive a 1½-hour infusion of irinotecan in weeks 1 and 3. Treatment with irinotecan may repeat every 8 weeks. Patients will also receive a 2-hour infusion of oxaliplatin in weeks 5 and 7. Treatment with oxaliplatin may repeat every 8 weeks. Some patients will also receive 30- to 90-minute infusion of bevacizumab every 2 weeks.

After finishing treatment, patients will be evaluated periodically.

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

Case Comprehensive Cancer Center

Smitha Krishnamurthi, MD, Protocol chair		Ph: 216-844-1160

U.S.A.
Ohio
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
	Geauga Regional Hospital
		Smitha Krishnamurthi	Ph:  216-844-5467
	Lake/University Ireland Cancer Center
		Smitha Krishnamurthi	Ph:  216-844-5467
	Mercy Cancer Center at Mercy Medical Center
		Smitha Krishnamurthi	Ph:  216-844-5467
	Southwest General Health Center
		Smitha Krishnamurthi	Ph:  216-844-5467
	UHHS Chagrin Highlands Medical Center
		Smitha Krishnamurthi	Ph:  216-844-5467
	UHHS Westlake Medical Center
		Smitha Krishnamurthi	Ph:  216-844-5467
	University Suburban Health Center
		Smitha Krishnamurthi	Ph:  216-844-5467

Registry Information
Official Title		Dose-Dense and Dose-Intense Alternating Irinotecan/Capecitabine and Oxaliplatin/Capecitabine: Phase I in Solid Tumors and Phase II With Bevacizumab a First-Line Therapy of Advanced Colorectal Cancer
Trial Start Date		2006-03-27
Trial Completion Date		2007-04-06 (estimated)
Registered in ClinicalTrials.gov		NCT00296062
Date Submitted to PDQ		2006-02-08
Information Last Verified		2008-12-13
NCI Grant/Contract Number		CA62502, CA43703