Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED 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

NCT00110019 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 823 participants
Start Date 2005-06
Est. Completion 2012-08
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

2,390 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00110019

The ClinicalTrials.gov registry entry for NCT00110019 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 823 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00110019 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arkansas, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00110019?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial