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NCT01041781 · ClinicalTrials.gov registry record · Phase 3
Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Terminated
- Registry status
- Phase 3
- Development phase
- 313
- Enrollment target
NCT01041781: Clinical Trial Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT01041781 is a Phase 3 study that was terminated before completion, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 313 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01041781, a Phase 3 study, was terminated before completion, sponsored by Alliance for Clinical Trials in Oncology.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 313 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving gemcitabine hydrochloride or pemetrexed disodium together with carboplatin is more effective with or without celecoxib in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, pemetrexed disodium, and carboplatin to compare how well they work when given together with celecoxib or a placebo in treating patients with advanced non-small cell lung cancer.
Primary Outcome
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Interventions
- OTHER placebo
- DRUG carboplatin
- DRUG gemcitabine hydrochloride
- DRUG pemetrexed disodium
- DRUG celecoxib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2010-02 |
| Est. Completion | 2018-03 |
| Phase | Phase 3 |
Why NCT01041781 stopped before completion
NCT01041781 is an interventional study that assigns participants to a tested intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT01041781 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01041781 about?
NCT01041781 is a clinical study titled "Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer". RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium and celecoxib may stop the growth of tumor cells by blocking some of ...
What is the current status of trial NCT01041781?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 313 participants. The study started on 2010-02. Estimated completion is 2018-03.
What interventions are being tested in trial NCT01041781?
The interventions under investigation include: placebo (OTHER), carboplatin (DRUG), gemcitabine hydrochloride (DRUG), pemetrexed disodium (DRUG), celecoxib (DRUG).
Who is sponsoring clinical trial NCT01041781?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01041781's enrollment target sits among peer trials
313 1101st of 2000 higher than 899 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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