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NCT00499655 · ClinicalTrials.gov registry record · Phase 2
Erlotinib Hydrochloride With or Without Celecoxib in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
NCT00499655: Completed Phase 2 study, sponsored by City of Hope Medical Center.
NCT00499655 is a Phase 2 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 107 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00499655, a Phase 2 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
Study Summary
RATIONALE: Erlotinib hydrochloride and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Celecoxib may also stop the growth of lung cancer by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with celecoxib may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving erlotinib hydrochloride together with celecoxib works compared with erlotinib hydrochloride alone in treating patients with stage IIIB-IV non-small cell lung cancer.
Primary Outcome
Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Interventions
- OTHER laboratory biomarker analysis
- OTHER placebo
- OTHER immunohistochemistry staining method
- DRUG erlotinib hydrochloride
- DRUG celecoxib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2007-11 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT00499655 record still lists
NCT00499655 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00499655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00499655 about?
NCT00499655 is a clinical study titled "Erlotinib Hydrochloride With or Without Celecoxib in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer". RATIONALE: Erlotinib hydrochloride and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Celecoxib may also stop the growth of lung cancer by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with celecoxib may kill more tumo...
What is the current status of trial NCT00499655?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2007-11. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00499655?
The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), immunohistochemistry staining method (OTHER), erlotinib hydrochloride (DRUG), celecoxib (DRUG).
Who is sponsoring clinical trial NCT00499655?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00499655's enrollment target sits among peer trials
107 646th of 2000 higher than 1,353 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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