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NCT00661427 · ClinicalTrials.gov registry record · Phase 2
Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer
A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT00661427: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00661427 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00661427, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
The purpose of this study is to find out what effects, good and/or bad, 2 doses of Cetuximab will have on head and neck cancer. The study is done because 250 mg/m2 given weekly does not work very well. Doses as high as 700 mg/m2 every other week appear to be no more toxic, so we will try to determine if 500 mg/m2 and 750 mg/m2 given every other week can work better. We do not know if it will help. We can use what we learn from this research study to help other people with the same disease.
Primary Outcome
Patients will be evaluated for response according to a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesions: Complete Response (CR): The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Partial Response (PR): At least a 30% decrease in the sum of the longest diamete
Interventions
- BIOLOGICAL cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2007-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT00661427 record still lists
NCT00661427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 1 intervention - of which cetuximab is the first listed.
NCT00661427 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00661427 about?
NCT00661427 is a clinical study titled "Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer". The purpose of this study is to find out what effects, good and/or bad, 2 doses of Cetuximab will have on head and neck cancer. The study is done because 250 mg/m2 given weekly does not work very well. Doses as high as 700 mg/m2 every other week appear to be no more toxic, so we will try to determin...
What is the current status of trial NCT00661427?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2007-11. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00661427?
The interventions under investigation include: cetuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00661427?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00661427's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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