A Study of the Perioperative Use of Cetuximab in Colon Cancer Patients
Status:
Terminated
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
There are more than 140,000 new cases of colon cancer diagnosed each year, and over 60,000
Americans die from colon cancer annually. To date, surgical resection remains the mainstay of
treatment for colon cancer. However, between 35% and 45% of patients, despite colon surgery,
retain unseen tumor cells in the bloodstream or in small clumps in the liver or other
tissues. It is for this reason that postoperative chemotherapy (anti-tumor drugs) is
recommended and given to some patients after surgery. Conventional chemotherapy is usually
started no earlier than 4 to 6 weeks after the colon cancer has been resected.
Despite surgery and conventional chemotherapy, a significant number of patients develop
cancer recurrences and many go on to die from the cancer. For this reason, investigators
continue to look for new cancer treatments and approaches. The study under consideration
proposes to give colon cancer patients an anti-cancer therapy for 3 weeks before and for 3
weeks after undergoing operation to remove the colon cancer. This time period is referred to
as the "perioperative period." Presently, around the world, doctors do not administer any
type of anti-cancer therapy during the perioperative period. It is the belief of the
investigators carrying out this study that this period may be an ideal time to fight the
tumor and that treatment given during this time may improve survival and reduce cancer
recurrence rates. Patients who choose to receive this biologic anti-cancer treatment
immediately before and after surgery can also receive conventional chemotherapy at the usual
time (4-6 weeks after surgery). Thus, this perioperative anti-cancer treatment would not
interfere with the standard chemotherapy regimens used today.
The drug that is to be given in this study is called Cetuximab (also known as "Erbitux").
This is an anti-cancer drug which has already been approved by the FDA for use in patients
who have colon cancer. This drug, like all of the other anti-cancer drugs used for treating
colon cancer, has been given either well after surgery or to patients with very advanced
disease who have not undergo surgery. What is unique about the St. Luke's Roosevelt study is
that the drug will be given during the 3 weeks before surgery and for the first 3 weeks after
the colon resection surgery.
To summarize, Cetuximab is a humanized antibody to EGFR which has been shown to be effective
in killing tumor cells in patients with colon cancer.
In this study the Cetuximab is to be given 1) after the surgery, 2) immediately before the
operation, or 3) both before and after surgery. Entry into the study means that the operation
may be delayed for at least 3 weeks in order for the drug to be given. Since many patients
who do not participate in any research studies wait at least that long for surgery this does
not constitute a delay. The drug has a safety profile and has been well tolerated, in
general. However, since thus far it has not been given in the weeks immediately prior to or
immediately after major surgery there is no safety profile for this drug during the
perioperative period. The primary goals of this preliminary study are to establish the safety
of Cetuximab in the perioperative period and to demonstrate that the preoperative doses have
an actual impact on the tumor cells themselves.