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NCT00828139 · ClinicalTrials.gov registry record · Phase 2
S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 189
- Enrollment target
NCT00828139: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00828139 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 189 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00828139, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 189 participants
- Enrollment target
Study Summary
This randomized phase II trial is studying topotecan to see how well it works when given with or without aflibercept in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combinations of biological substances in aflibercept may be able to carry tumor-killing substances directly to small cell lung cancer cells. Aflibercept may also stop the growth of small cell lung cancer by blocking blood flow to the tumor. It is not yet known whether topotecan is more effective with or without aflibercept in treating patients with small cell lung cancer.
Primary Outcome
From the date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Progression is defined as 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion
Interventions
- DRUG topotecan hydrochloride
- BIOLOGICAL ziv-aflibercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2009-05 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
What the finished NCT00828139 record still lists
NCT00828139 is an interventional study that assigns participants to a tested intervention. The registered 189 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 (42% higher).
The record links to 0 conditions, and to 2 interventions - of which topotecan hydrochloride is the first listed.
NCT00828139 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00828139 about?
NCT00828139 is a clinical study titled "S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer". This randomized phase II trial is studying topotecan to see how well it works when given with or without aflibercept in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by ki...
What is the current status of trial NCT00828139?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 189 participants. The study started on 2009-05. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00828139?
The interventions under investigation include: topotecan hydrochloride (DRUG), ziv-aflibercept (BIOLOGICAL).
Who is sponsoring clinical trial NCT00828139?
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 NCT00828139's enrollment target sits among peer trials
189 355th of 2000 higher than 1,645 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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