Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00494611 · ClinicalTrials.gov registry record · Phase 1
A Study of the Perioperative Use of Cetuximab in Colon Cancer Patients
A Phase 1 study, sponsored by St. Luke's-Roosevelt Hospital Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT00494611 is a Phase 1 study that was terminated before completion, run by St. Luke's-Roosevelt Hospital Center. The registered enrollment target is 25 participants.
The verdict
NCT00494611, a Phase 1 study, was terminated before completion, sponsored by St. Luke's-Roosevelt Hospital Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study 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
Interventions
- DRUG Peri operative Cetuximab.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00494611
The ClinicalTrials.gov registry entry for NCT00494611 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Luke's-Roosevelt Hospital Center, which has 57 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Peri operative Cetuximab. is the first listed.
NCT00494611 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00494611 about?
NCT00494611 is a clinical study titled "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 ce...
What is the current status of trial NCT00494611?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2007-09. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00494611?
The interventions under investigation include: Peri operative Cetuximab. (DRUG).
Who is sponsoring clinical trial NCT00494611?
This trial is sponsored by St. Luke's-Roosevelt Hospital Center, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.