Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Nasser Hanna, M.D..
NCT00216203 is a Phase 1 study that has completed, run by Nasser Hanna, M.D.. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab
Interventions
- DRUG Pemetrexed
- DRUG Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2005-05 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
What the finished NCT00216203 record still lists
NCT00216203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Pemetrexed is the first listed.
NCT00216203 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00216203's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia