Phase II Study of Treatment Selection Based Upon Tumor Thymidylate Synthase Expression in Previously Untreated Patients With Metastatic Colorectal Cancer
|Phase II||Treatment||Closed||18 and over||NCI||ECOG-E4203|
Special Category: NCI Web site featured trial, NCI - CMS pilot project trial
Drugs used in chemotherapy, such as oxaliplatin, irinotecan, leucovorin, and fluorouracil, 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 colorectal cancer by blocking blood flow to the tumor. Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth. Studying the amount of an enzyme found in the tumor may help doctors plan the best treatment.
This randomized phase II trial is studying giving bevacizumab, oxaliplatin, and irinotecan or giving bevacizumab, oxaliplatin, leucovorin, and fluorouracil in treating patients with metastatic or recurrent colorectal cancer.
Eligibility criteria include the following:
- At least 18 years old
- Measurable disease
- More than 4 weeks since surgery or biopsy
- 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.
Patients will be randomly assigned (have an equal chance of being placed in one of three treatment groups).
Patients in group one will receive a 30-90 minute infusion of bevacizumab, a 2-hour infusion of oxaliplatin, and a 90-minute infusion of irinotecan in weeks 1 and 3.
Patients in groups two and three will receive bevacizumab and oxaliplatin as in group one, a 2-hour infusion of leucovorin, and a 2-day continuous infusion of fluorouracil in weeks 1 and 3.
In all groups, treatment may repeat every 4 weeks for as long as benefit is shown.
Patients will be evaluated periodically for 4 years.
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 Lead Organizations
Eastern Cooperative Oncology Group
|Neal Meropol, MD, Protocol chair (Contact information may not be current)|
|Jean Grem, MD, Protocol co-chair|
|Official Title||Phase II Study of Treatment Selection Based Upon Tumor Thymidylate Synthase Expression in Previously Untreated Patients With Metastatic Colorectal Cancer|
|Trial Start Date||2005-07-14|
|Trial Completion Date||2013-11-30 (estimated)|
|Registered in ClinicalTrials.gov||NCT00098787|
|Date Submitted to PDQ||2004-10-13|
|Information Last Verified||2012-04-18|
|NCI Grant/Contract Number||CA21115|