Related Links Educational Materials About Clinical Trials Clinical Trials: Questions and Answers Questions to Ask Your Doctor Drug Information from MedlinePlus

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

Alternate Title

Pilot Study of Neoadjuvant Chemotherapy Comprising Oxaliplatin, Fluorouracil, Leucovorin Calcium (FOLFOX), and Bevacizumab With or Without Radiotherapy in Patients With Locally Advanced Rectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Active	18 and over	NCI	MSKCC-07021 07-021, NCT00462501

Trial Description

Purpose:

Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, 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 rectal cancer by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy and bevacizumab together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

This clinical trial is studying how well giving combination chemotherapy and bevacizumab with or without radiation therapy works in treating patients with locally advanced rectal cancer

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No metastatic cancer
• No previous chemotherapy or surgery for rectal cancer
• No previous radiation therapy to the pelvis
• 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 2-hour infusions of oxaliplatin and leucovorin and an infusion of bevacizumab on day 1 and a 2-day continuous infusion of fluorouracil on days 1 and 2 in weeks 1, 3, 5, and 7. They will then receive 2-hour infusions of oxaliplatin and leucovorin on day 1 and a 2-day continuous infusion of fluorouracil on days 1 and 2 in weeks 9 and 11.

Within 4-6 weeks after finishing chemotherapy, some patients will undergo surgery to remove the tumor.

Other patients will undergo radiation therapy to the pelvis 5 days a week and will receive a continuous infusion of fluorouracil for 5½ weeks. Four to seven weeks later, they will undergo surgery to remove the tumor.

After finishing treatment, patients will be evaluated every 3 months for 1 year and every 6 months for 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

Memorial Sloan-Kettering Cancer Center

Leonard Saltz, MD, Principal investigator		Ph: 212-639-2501; 800-525-2225
Karyn Goodman, MD, Principal investigator		Ph: 212-639-3983 ; 800-525-2225
Martin Weiser, MD, Principal investigator		Ph: 212-639-6698; 800-525-2225 Email: weiser1@mskcc.org

U.S.A.
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Leonard Saltz, MD	Ph:  212-639-2501 800-525-2225

See All Trial Sites

Registry Information
Official Title		A Pilot Study of Neoadjuvant Chemotherapy with Selective Use of Radiation for Locally Advanced Rectal Cancer
Trial Start Date		2007-03-20
Trial Completion Date		2009-12-01 (estimated)
Registered in ClinicalTrials.gov		NCT00462501
Date Submitted to PDQ		2007-03-15
Information Last Verified		2008-12-14
NCI Grant/Contract Number		CA08748