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NCT00126581 · ClinicalTrials.gov registry record · Phase 2
Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 188
- Enrollment target
NCT00126581: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00126581 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 188 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00126581, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 188 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well erlotinib hydrochloride with or without carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving erlotinib hydrochloride together with carboplatin and paclitaxel may kill more tumor cells than giving either drug alone.
Primary Outcome
The product limit estimator developed by Kaplan Meier will be used to graphically describe progression free survival for patients randomized to each study arm. The 18 week progression-free survival rate was defined as the proportion of patients that were alive progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Erlotinib
- DRUG Erlotinib Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2005-08-15 |
| Est. Completion | 2017-11-28 |
| Phase | Phase 2 |
What the finished NCT00126581 record still lists
NCT00126581 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT00126581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00126581 about?
NCT00126581 is a clinical study titled "Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer". This randomized phase II trial studies how well erlotinib hydrochloride with or without carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growt...
What is the current status of trial NCT00126581?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 188 participants. The study started on 2005-08-15. Estimated completion is 2017-11-28.
What interventions are being tested in trial NCT00126581?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Erlotinib (DRUG), Erlotinib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00126581?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00126581's enrollment target sits among peer trials
188 356th of 2000 higher than 1,644 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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