|
Introduction
The National Cancer Institute (NCI) has temporarily suspended the enrollment of
patients in a
clinical trial that is evaluating
bevacizumab (Avastin™), an investigational
antiangiogenic agent, for patients with locally advanced or
metastatic colorectal cancer who are no longer benefiting from
standard treatments. The study reached its initial accrual goal on
October 31, 2003. Per the study protocol, enrollment will be suspended until
sufficient evidence of anti-tumor activity is demonstrated.
Based on an interim analysis in February 2004, there does not appear to be
sufficient number of responses to warrant re-opening the trial for additional
patient accrual. However, patients already enrolled in the study who have
stable disease will continue to be observed for response to Avastin;
researchers expect the next decision point regarding the status of this trial
in late March. If there is evidence of clinical benefit and the agent is not
commercially available at that time, the study will re-open for enrollment.
This treatment referral center trial (TRC-0301) was developed by NCI's Cancer
Therapy Evaluation Program (CTEP) in collaboration with Genentech, Inc., the
manufacturer of bevacizumab. The trial enrolled patients who had previously
received both
oxaliplatin- and
irinotecan-based chemotherapy regimens, but were no longer benefiting
from these standard therapies. Patients in the trial receive bevacizumab in
combination with 5-fluorouracil (5-FU)
and
leucovorin.
For information about clinical trials that are currently enrolling patients with
metastatic colorectal cancer, contact the NCI's Cancer Information Service
toll-free, Monday through Friday, 9 a.m. to 4:30 p.m., at 1-800-4-CANCER
(1-800-422-6237) for information in English or Spanish. The number for callers
with TTY equipment is 1-800-332-8615.
Next Section > |
