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NCT00216203 · ClinicalTrials.gov registry record · Phase 1
Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer
A Phase 1 study, sponsored by Nasser Hanna, M.D..
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00216203 is a Phase 1 study that has completed, run by Nasser Hanna, M.D.. The registered enrollment target is 36 participants.
The verdict
NCT00216203, a Phase 1 study, has completed, sponsored by Nasser Hanna, M.D..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this study is to determine the feasibility of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating the activity of the combination in an expanded phase II setting. If the combination appears to have promising activity, further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone.
Interventions
- DRUG Pemetrexed
- DRUG Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2005-05 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00216203
The ClinicalTrials.gov registry entry for NCT00216203 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nasser Hanna, M.D., which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pemetrexed is the first listed.
NCT00216203 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00216203 about?
NCT00216203 is a clinical study titled "Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer". Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore,...
What is the current status of trial NCT00216203?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2005-05. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00216203?
The interventions under investigation include: Pemetrexed (DRUG), Cetuximab (DRUG).
Who is sponsoring clinical trial NCT00216203?
This trial is sponsored by Nasser Hanna, M.D., which has 8 total clinical trials registered on ClinicalTrials.gov.
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