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NCT00738881 · ClinicalTrials.gov registry record · Phase 3
Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-small Cell Lung Cancer
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 3
- Development phase
- 23
- Enrollment target
NCT00738881: Clinical Trial Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00738881 is a Phase 3 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 23 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00738881, a Phase 3 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 23 participants
- Enrollment target
Study Summary
This randomized phase III trial studies pemetrexed disodium to see how well it works compared with erlotinib hydrochloride as second-line therapy in treating patients with non-small cell lung cancer that has spread to other places in the body. Pemetrexed disodium and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed disodium is more effective than erlotinib hydrochloride in treating advanced non-small cell lung cancer.
Primary Outcome
Estimated using the method of Kaplan-Meier survival curves to compare PFS between the erlotinib and pemetrexed arms using an intent-to-treat (ITT) analysis. Due to the small sample size (21 of the required 954 patients \~2%), analyses within the FISH(+) and FISH(-) groups were not performed, and no formal analyses for the primary or the secondary efficacy outcomes were performed.
Interventions
- DRUG Erlotinib Hydrochloride
- DRUG Pemetrexed Disodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2008-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
Why NCT00738881 stopped before completion
NCT00738881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Erlotinib Hydrochloride is the first listed.
NCT00738881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00738881 about?
NCT00738881 is a clinical study titled "Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-small Cell Lung Cancer". This randomized phase III trial studies pemetrexed disodium to see how well it works compared with erlotinib hydrochloride as second-line therapy in treating patients with non-small cell lung cancer that has spread to other places in the body. Pemetrexed disodium and erlotinib hydrochloride may stop...
What is the current status of trial NCT00738881?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 23 participants. The study started on 2008-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00738881?
The interventions under investigation include: Erlotinib Hydrochloride (DRUG), Pemetrexed Disodium (DRUG).
Who is sponsoring clinical trial NCT00738881?
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 NCT00738881's enrollment target sits among peer trials
23 1952nd of 2000 higher than 48 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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