Clinical trial to test personalized approach to chemotherapy for metastatic colorectal cancer based on thymidylate synthase level
Posted by Kate Murphy on November 19th, 2006
FEATURED CLINICAL TRIAL: ECOG-E4203
People with colon or rectal cancer that has spread (metastasized) may have different levels of a protein called thymidylate synthase (TS) in their tumors. Previous studies have suggested that tumors with high levels of TS may be resistant to 5FU treatment.
Researchers want to know if replacing 5FU (fluorouracil) with irinotecan (Camptosar®) will improve the response to chemotherapy in patients with high TS levels.
A phase II clinical trial for first-line treatment of metastatic colorectal cancer ( ECOG-E4203 ) will test levels of thymidylate synthase in colon or rectal tumors and assign treatment strategies based on those results.
Patients with high levels of TS will randomly receive either:
- Arm 1: An experimental treatment consisting of oxaliplatin (Eloxatin®) and irinotecan (Camptosar®) plus bevacizumab (Avastin®) at the beginning of each two week cycle.
- Arm II: The current standard treatment of FOLFOX plus bevacizumab. Bevacizumab and oxaliplatin are given intravenously on the first day followed by a two-day continuous infusion of 5FU. The cycle is repeated every two weeks.
Patients with low TS levels will be given the same standard FOLFOX plus bevacizumab treatment as in Arm II.
WHO IS ELIGIBLE FOR THE TRIAL?
- Patients with colon or rectal cancer that has spread (metastatic)
- No previous treatment for metastatic disease (first-line.)
- No serious heart or kidney disease, uncontrolled high blood pressure, or neuropathy.
- Tumor that can be measured.
WHERE IS THE TRIAL AVAILABLE?
The trial is being conducted by the Eastern Cooperative Oncology Group under the leadership of Neal Jay Meropol, 
M.D. and Jean Grem M.D. at community sites across the United States.
A list of sites and contacts is available on Cancer.Gov or can be obtained by calling NCI’s Cancer Information Service at 1-800-4-CANCER.
Additional help in enrolling or in finding a different clinical trial to meet your needs is available through the C3 Clinical Trials Matching Service at 1-866-278-0392.
ECOG-E4203 is one of the clinical trials eligible for special Medicare coverage under the Medicare Anti-Cancer Drugs National Coverage Decision. While Medicare covers the routine costs of cancer clinical trials, the nine trials that are part of the 2005 NCD have additional nonroutine expenses paid, as well as off-label uses of cancer drugs.
