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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: Clinical Trial Phase 1 study, sponsored by St. Luke's-Roosevelt Hospital Center.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00494611 stopped before completion
NCT00494611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Peri operative Cetuximab. is the first listed.
NCT00494611 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00494611's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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