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NCT00110019 · ClinicalTrials.gov registry record · Phase 3
Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
A Phase 3 study of Recurrent Melanoma and Mucosal Melanoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 823
- Enrollment target
- 20
- Study locations
NCT00110019: Completed Phase 3 study of Recurrent Melanoma and Mucosal Melanoma, sponsored by National Cancer Institute (NCI).
NCT00110019 is a Phase 3 study of Recurrent Melanoma and Mucosal Melanoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 823 participants, above the 137-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (501% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00110019, a Phase 3 study of Recurrent Melanoma and Mucosal Melanoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 823 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies carboplatin, paclitaxel, and sorafenib tosylate to see how well they work compared to carboplatin and paclitaxel in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with sorafenib tosylate is more effective than carboplatin and paclitaxel in treating melanoma.
Primary Outcome
Overall survival is defined as time from study entry to death from any cause. The comparison of overall survival was conducted in intention-to-treat population.
Conditions Studied
Interventions
- DRUG Carboplatin
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- OTHER Pharmacological Study
Study Locations (20)
California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- City of Hope Comprehensive Cancer Center - Duarte
- Marin Cancer Care Inc - Greenbrae
- UC San Diego Moores Cancer Center - La Jolla
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Bay Area Tumor Institute - Oakland
- Saint Joseph Hospital - Orange - Orange
- Stanford Cancer Institute - Palo Alto
- Kaiser Permanente-Redwood City - Redwood City
- Kaiser Permanente-Richmond - Richmond
- Kaiser Permanente-Roseville - Roseville
- Kaiser Permanente - Sacramento - Sacramento
- Kaiser Permanente-San Diego Mission - San Diego
- Veterans Administration-San Diego Medical Center - San Diego
- Kaiser Permanente-San Francisco - San Francisco
- California Pacific Medical Center-Pacific Campus - San Francisco
- Kaiser Permanente-Santa Teresa-San Jose - San Jose
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- University of Arkansas for Medical Sciences - Little Rock
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 823 participants |
| Start Date | 2005-06 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
What the finished NCT00110019 record still lists
NCT00110019 is an interventional study that assigns participants to a tested intervention. The registered 823 participants enrollment target is mid-sized for trials with a published cap, above the 137-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (501% higher).
The record links to 6 conditions, with Recurrent Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT00110019 names 20 study sites across 3 states, led by California, Arkansas, Alabama.
Frequently Asked Questions
What is clinical trial NCT00110019 about?
NCT00110019 is a clinical study titled "Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery". This randomized phase III trial studies carboplatin, paclitaxel, and sorafenib tosylate to see how well they work compared to carboplatin and paclitaxel in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and pac...
What is the current status of trial NCT00110019?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 823 participants. The study started on 2005-06. Estimated completion is 2012-08.
What conditions does trial NCT00110019 study?
This clinical trial studies the following conditions: Recurrent Melanoma, Mucosal Melanoma, Stage IV Skin Melanoma, Stage IIIA Skin Melanoma, Stage IIIB Skin Melanoma.
What interventions are being tested in trial NCT00110019?
The interventions under investigation include: Carboplatin (DRUG), Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT00110019?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00110019 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00110019's enrollment target sits among peer trials
823 2nd of 23 the highest of 23 other Recurrent Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Melanoma 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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Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
ACTIVE NOT RECRUITING · Phase 2
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