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NCT00240097 · ClinicalTrials.gov registry record · Phase 2
Study of Sequential Topoisomerase, Irinotecan/Oxaliplatin - Etoposide /Carboplatin in Extensive Small Cell Lung Cancer (SCLC)
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00240097: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT00240097 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00240097, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The primary objective of Part I of the study is to determine tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide /carboplatin in chemotherapy-naïve patients with extensive small cell lung cancer. The primary objective of Part II of the study is to determine the objective tumor response rate of irinotecan/oxaliplatin in patients with either refractory disease or who have relapsed to first line chemotherapy or chemoradiotherapy.
Primary Outcome
The primary objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) - IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response
Interventions
- DRUG Intervention A: Irinotecan; Oxaliplatin; Neulasta
- DRUG Intervention B: Etoposide; Carboplatin; Neulasta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2005-06 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
What the finished NCT00240097 record still lists
NCT00240097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Intervention A: Irinotecan; Oxaliplatin; Neulasta is the first listed.
NCT00240097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00240097 about?
NCT00240097 is a clinical study titled "Study of Sequential Topoisomerase, Irinotecan/Oxaliplatin - Etoposide /Carboplatin in Extensive Small Cell Lung Cancer (SCLC)". The primary objective of Part I of the study is to determine tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide /carboplatin in chemotherapy-naïve patients with extensive small cell lung cancer. The primary objective of Part II of the study is...
What is the current status of trial NCT00240097?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2005-06. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00240097?
The interventions under investigation include: Intervention A: Irinotecan; Oxaliplatin; Neulasta (DRUG), Intervention B: Etoposide; Carboplatin; Neulasta (DRUG).
Who is sponsoring clinical trial NCT00240097?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00240097's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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