Treatment Based on Colorectal Tumor Protein Level
Name of the Trial
Why This Trial Is Important
The drug fluorouracil (5-FU) is often used to treat colorectal cancer; however, previous clinical studies suggest that tumors with a high level of the protein thymidylate synthase (TS) are more likely to be resistant to 5-FU treatment.
In this trial, researchers will measure the level of TS in the tumors of patients with metastatic colorectal cancer. Patients whose tumors show a low level of TS will be treated with combination chemotherapy consisting of 5-FU, leucovorin calcium, and oxaliplatin (the so-called "FOLFOX" regimen) plus the monoclonal antibody bevacizumab. Patients whose tumors show a high level of TS will be treated either with the same drug combination plus bevacizumab or with an investigational combination of the drugs oxaliplatin and irinotecan plus bevacizumab. Researchers want to determine whether replacing 5-FU and leucovorin calcium with irinotecan will lead to better response rates and survival in these patients.
"As the array of treatments for metastatic colorectal cancer expands, it's important to match specific treatments with those patients who are most likely to benefit from them," said Dr. Meropol. "This is the first national study for patients with metastatic colorectal cancer to prospectively assign treatment based on the molecular characteristics of the tumor."
Who Can Join This Trial
Study Sites and Contact Information
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