A Study of the Perioperative Use of Cetuximab in Colon Cancer Patients
Public ClinicalTrials.gov record NCT00494611. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00494611
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2007 (Type not available)
- Primary completion
- Nov 2010 (Actual)
- Completion
- Nov 2010 (Actual)
- Last update posted
- May 19, 2011
2007 – 2010
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St Luke's Roosevelt Medical Center | New York | New York | 10019 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00494611, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 19, 2011 · Synced Oct 9, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00494611 live on ClinicalTrials.gov.