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NCT00856830 · ClinicalTrials.gov registry record · Phase 1
Bendamustine With Irinotecan Followed by Etoposide/Carboplatin for Patients With Extensive Stage Small Cell Lung Cancer
A Phase 1 study of Small-cell Lung Cancer and Extensive Stage Lung Cancer, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT00856830 is a Phase 1 study of Small-cell Lung Cancer and Extensive Stage Lung Cancer that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 30 participants, below the 232-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00856830, a Phase 1 study of Small-cell Lung Cancer and Extensive Stage Lung Cancer, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
Small cell lung cancer, or SCLC, constitutes approximately 15% of the 170,000 new cases of lung cancer diagnosed annually in the United States. Extensive-stage SCLC comprises two thirds of new cases and is generally considered sensitive to chemotherapy, despite a median time to progression of 4 months. SCLC is one of the most aggressive and lethal types of cancer, with a median survival of 9 months (range 7-11 months) in patients diagnosed with extensive disease. Overall, the majority of patients with SCLC die in less than 2 years (2-year survival rates generally less than 10%), and the 5-year survival rate is 2.3% for patients with extensive disease. The regimen of etoposide in combination with a platinum (cisplatin or carboplatin) is generally considered the "standard of care" although a recent Phase III trial suggests improved survival with the combination of cisplatin/irinotecan. Further evaluation of new agents in combination regimens attempting to overcome the intrinsic drug resistance seen in extensive-stage SCLC is warranted attempting to improve survival and achieve palliation of disease-related symptoms.
Conditions Studied
Interventions
- DRUG Novel Drug Combination
Study Locations (2)
Alabama
- University of Alabama at Birmingham - Birmingham
Georgia
- Georgia Cancer Specialists - Marietta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-04 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00856830
The ClinicalTrials.gov registry entry for NCT00856830 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 232-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (87% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Novel Drug Combination is the first listed.
NCT00856830 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Alabama, Georgia.
Frequently Asked Questions
What is clinical trial NCT00856830 about?
NCT00856830 is a clinical study titled "Bendamustine With Irinotecan Followed by Etoposide/Carboplatin for Patients With Extensive Stage Small Cell Lung Cancer". Small cell lung cancer, or SCLC, constitutes approximately 15% of the 170,000 new cases of lung cancer diagnosed annually in the United States. Extensive-stage SCLC comprises two thirds of new cases and is generally considered sensitive to chemotherapy, despite a median time to progression of 4 mont...
What is the current status of trial NCT00856830?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2009-04. Estimated completion is 2016-05.
What conditions does trial NCT00856830 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer, Extensive Stage Lung Cancer, Chemonaive.
What interventions are being tested in trial NCT00856830?
The interventions under investigation include: Novel Drug Combination (DRUG).
Who is sponsoring clinical trial NCT00856830?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00856830 being conducted?
This trial has 2 study locations across Alabama, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.