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NCT00438204 · ClinicalTrials.gov registry record · Phase 2
Pemetrexed Disodium, Gemcitabine, and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT00438204: Clinical Trial Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT00438204 is a Phase 2 study that was terminated before completion, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00438204, a Phase 2 study, was terminated before completion, sponsored by Barbara Ann Karmanos Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium and gemcitabine together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and gemcitabine together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Primary Outcome
RECIST criteria for tumor progression of at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Interventions
- BIOLOGICAL bevacizumab
- DRUG gemcitabine hydrochloride
- DRUG pemetrexed disodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2006-05 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
Why NCT00438204 stopped before completion
NCT00438204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 3 interventions - of which bevacizumab is the first listed.
NCT00438204 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00438204 about?
NCT00438204 is a clinical study titled "Pemetrexed Disodium, Gemcitabine, and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer". RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclon...
What is the current status of trial NCT00438204?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2006-05. Estimated completion is 2016-06.
What interventions are being tested in trial NCT00438204?
The interventions under investigation include: bevacizumab (BIOLOGICAL), gemcitabine hydrochloride (DRUG), pemetrexed disodium (DRUG).
Who is sponsoring clinical trial NCT00438204?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00438204's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 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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