A Study of the Perioperative Use of Cetuximab in Colon Cancer Patients
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study of the Perioperative Use of Cetuximab in Colon Cancer Patients|
- Safety of peri operative Cetuximab. [ Time Frame: within 90 days of surgery ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Drug: Peri operative Cetuximab.
Cetuximab's tumor growth inhibitory mechanism directly blocks EGFR. After binding to EGFR, the antibody blocks signal transduction through the receptor with a subsequent inhibition of tumor cell proliferation and MMP expression. We hypothesize that peri-operative weekly administration of Cetuximab, a humanized monoclonal antibody to EGF receptor (EGFR), for 3 weeks immediately prior to surgery and for 3 weeks immediately after colon cancer surgery is safe. This drug has been demonstrated to be effective in Stage 4 colon cancer patients and is approved for use in colorectal cancer patients. Cetuximab has never been administered in the month immediately before or after colon surgery. Establishing the safety of Cetuximab in the perioperative setting is the primary objective of this study.
|United States, New York|
|St Luke's Roosevelt Medical Center|
|New York, New York, United States, 10019|
|Study Chair:||Richard L Whelan, MD||Columbia University|