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NCT00305942 · ClinicalTrials.gov registry record · Phase 2
Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
A Phase 2 study of Carcinoma, Small Cell, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 16
- Study locations
NCT00305942: Completed Phase 2 study of Carcinoma, Small Cell, sponsored by SCRI Development Innovations.
NCT00305942 is a Phase 2 study of Carcinoma, Small Cell that has completed, run by SCRI Development Innovations. The registered enrollment target is 61 participants, below the 106-participant average among 3 other Carcinoma, Small Cell trials with a reported enrollment target (42% lower). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00305942, a Phase 2 study of Carcinoma, Small Cell, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 16
- Study locations
Study Summary
This proposed phase II trial will investigate the combination of topotecan/carboplatin in the first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are emerging as common treatments for patients with extensive-stage disease. This trial will be one of the first clinical trials to evaluate a combination of weekly topotecan and carboplatin in the first-line treatment of extensive-stage SCLC.
Primary Outcome
Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum
Conditions Studied
Interventions
- DRUG Topotecan
- DRUG carboplatin
Study Locations (16)
Tennessee
- Associates in Hematology Oncology - Chattanooga
- Family Cancer Center - Collierville
- Tennessee Oncology, PLLC - Nashville
Florida
- Florida Cancer Specialists - Fort Myers
- Watson Clinic Center for Cancer Care and Research - Lakeland
Kentucky
- Graves-Gilbert Clinic - Bowling Green
- Consultants in Blood Disorders and Cancer - Louisville
Alabama
- Northeast Alabama Regional Medical Center - Anniston
Arkansas
- Northeast Arkansas Clinic - Jonesboro
Georgia
- Northeast Georgia Medical Center - Gainesville
Louisiana
- Hematology Oncology Life Center - Alexandria
Maine
- Mercy Hospital - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2006-03 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
What the finished NCT00305942 record still lists
NCT00305942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 106-participant average among 3 other Carcinoma, Small Cell trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Carcinoma, Small Cell appearing as the primary indexed condition, and to 2 interventions - of which Topotecan is the first listed.
NCT00305942 lists 16 locations in 12 states (Tennessee, Florida, Kentucky).
Frequently Asked Questions
What is clinical trial NCT00305942 about?
NCT00305942 is a clinical study titled "Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer". This proposed phase II trial will investigate the combination of topotecan/carboplatin in the first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are emerging as common treatments for patients with extensive-stage disease. This trial will be one of the first clini...
What is the current status of trial NCT00305942?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2006-03. Estimated completion is 2009-11.
What conditions does trial NCT00305942 study?
This clinical trial studies the following conditions: Carcinoma, Small Cell.
What interventions are being tested in trial NCT00305942?
The interventions under investigation include: Topotecan (DRUG), carboplatin (DRUG).
Who is sponsoring clinical trial NCT00305942?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00305942 being conducted?
This trial has 16 study locations across Alabama, Arkansas, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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