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Continuing Bevacizumab Therapy for Metastatic Colorectal Cancer
Untitled Document
Name of the Trial
Phase III Randomized Study of Irinotecan Hydrochloride-Based Chemotherapy and
Cetuximab With Versus Without Bevacizumab in Patients With Metastatic Colorectal
Cancer That Progressed on First-Line Therapy (SWOG-S0600). See the protocol
summary.
Principal Investigators
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Dr. Philip Gold
Principal Investigator |
Dr. Philip Gold and Dr. Anthony Shields, Southwest Oncology Group; Dr. Axel
Grothey, North Central Cancer Treatment Group; Dr. Leonard Saltz, Cancer and
Leukemia Group B; Dr. Steven Cohen, Eastern Cooperative Oncology Group; and
Dr. Scott Berry, NCIC-Clinical Trials Group.
Why This Trial Is Important
Patients with metastatic colorectal cancer are often treated with the drug
oxaliplatin and the monoclonal antibody bevacizumab in combination with other
drugs. If the cancer progresses while the patient is being treated with these
agents, second-line therapy with different drugs may be initiated.
Bevacizumab inhibits the formation of new blood vessels that tumors need for
continued growth and has been shown to help extend the survival of patients
with advanced or metastatic colorectal cancer when used as part of initial,
or first-line, therapy. It is unknown, however, whether continuing bevacizumab
treatment will help improve survival when used in second-line therapy in patients
whose cancer has progressed despite first-line treatment with bevacizumab and
chemotherapy.
In this trial, patients with metastatic colorectal cancer that has progressed
on first-line therapy containing oxaliplatin and bevacizumab will be treated
with the agents irinotecan and cetuximab. The patients will also be randomly
assigned to receive either a low dose of bevacizumab, a high dose of bevacizumab,
or no additional bevacizumab.
"The goal of this trial is to determine whether there is benefit in continuing
to treat patients with bevacizumab if they have progressed on a regimen containing
it," said Dr. Gold.
"Bevacizumab may make tumors more susceptible to chemotherapy by normalizing
the tumor vasculature, and emerging data suggest that bevacizumab and cetuximab
may produce a synergistic effect," Dr. Gold added. "So, there is a
good rationale to see if continuing bevacizumab in combination with cetuximab
will help improve outcomes for patients, perhaps helping them live longer."
For More Information
See the lists of entry
criteria and trial contact information at or call the NCI's Cancer Information
Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.
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