Trial · NCT00110019
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, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2012-09-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery. Trials, record NCT00110019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00110019
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
- NCT number
- NCT00110019
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 823 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Mucosal Melanoma, Recurrent Melanoma, Stage IIIA Skin Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma, Stage IV Skin Melanoma
- Interventions
- Carboplatin, Laboratory Biomarker Analysis, Paclitaxel, Pharmacological Study, Placebo, Sorafenib Tosylate
- First posted
- 2005-05-04
- Last updated
- 2015-10-19
- Results first posted
- 2012-09-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry. | 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. |
| Secondary | Progression-free Survival | Tumor response was assessed after every 2 cycles during cycle 1 through 10, and every 3 cycles after cycle 10. Survival was assessed every 3 months if patient is < 2 years from study entry, and every 6 months if 2-5 years from study entry. | Progression-free survival was defined as time from study entry to disease progression or death from any cause, whichever occurred first. Patients without disease progression were censored at last date of assessment. Disease progression was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. |
| Secondary | Objective Response (Complete and Partial Response) Rate | Tumor response was assessed after every 2 cycles during cycle 1 through 10. After cycle 10, tumor response was assessed after every 3 cycles. | Tumor response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Objective response =complete response (CR) + partial response (PR). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of longest diameters. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry. | Intention-to-treat population, n=823 | months | MEDIAN |
| SECONDARY | Progression-free Survival | Tumor response was assessed after every 2 cycles during cycle 1 through 10, and every 3 cycles after cycle 10. Survival was assessed every 3 months if patient is < 2 years from study entry, and every 6 months if 2-5 years from study entry. | Intention-to-treat population, n=821, two patients had no information about date of progression, and were excluded from the analysis | months | MEDIAN |
| SECONDARY | Objective Response (Complete and Partial Response) Rate | Tumor response was assessed after every 2 cycles during cycle 1 through 10. After cycle 10, tumor response was assessed after every 3 cycles. | Intention-to-treat population, n=823 | proportion | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Arm I (Carboplatin + Paclitaxel + Sorafenib) | 11.1 | 95% Confidence Interval 10.3 to 12.3 | months | |
| Overall Survival | Arm II (Carboplatin + Paclitaxel+Placebo) | 11.3 | 95% Confidence Interval 9.8 to 12.2 | months | |
| Progression-free Survival | Arm I (Carboplatin + Paclitaxel + Sorafenib) | 4.9 | 95% Confidence Interval 4.5 to 5.6 | months | |
| Progression-free Survival | Arm II (Carboplatin + Paclitaxel+Placebo) | 4.2 | 95% Confidence Interval 3.4 to 4.7 | months | |
| Objective Response (Complete and Partial Response) Rate | Arm I (Carboplatin + Paclitaxel + Sorafenib) | 0.205 | 95% Confidence Interval 0.167 to 0.247 | proportion | |
| Objective Response (Complete and Partial Response) Rate | Arm II (Carboplatin + Paclitaxel+Placebo) | 0.182 | 95% Confidence Interval 0.146 to 0.222 | proportion |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Carboplatin+Paclitaxel+Sorafenib) | 410 | |
| Overall Study | STARTED | Arm II (Carboplatin+Paclitaxel) | 413 | |
| Overall Study | Eligible | Arm I (Carboplatin+Paclitaxel+Sorafenib) | 395 | |
| Overall Study | Eligible | Arm II (Carboplatin+Paclitaxel) | 398 | |
| Overall Study | Treated | Arm I (Carboplatin+Paclitaxel+Sorafenib) | 393 | |
| Overall Study | Treated | Arm II (Carboplatin+Paclitaxel) | 397 | |
| Overall Study | COMPLETED | Arm I (Carboplatin+Paclitaxel+Sorafenib) | 4 | |
| Overall Study | COMPLETED | Arm II (Carboplatin+Paclitaxel) | 0 | |
| Overall Study | NOT COMPLETED | Arm I (Carboplatin+Paclitaxel+Sorafenib) | 406 | |
| Overall Study | NOT COMPLETED | Arm II (Carboplatin+Paclitaxel) | 413 |
Source ClinicalTrials.gov
Adverse events430
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm I (Carboplatin + Paclitaxel + Sorafenib) | 191 | 393 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Carboplatin + Paclitaxel+Placebo) | 195 | 397 | |
| other | Leukopenia | Investigations | Arm I (Carboplatin + Paclitaxel + Sorafenib) | 135 | 393 | |
| other | Leukopenia | Investigations | Arm II (Carboplatin + Paclitaxel+Placebo) | 146 | 397 | |
| other | Lymphopenia | Investigations | Arm I (Carboplatin + Paclitaxel + Sorafenib) | 38 | 393 | |
| other | Lymphopenia | Investigations | Arm II (Carboplatin + Paclitaxel+Placebo) | 29 | 397 | |
| other | Neutropenia | Investigations | Arm I (Carboplatin + Paclitaxel + Sorafenib) | 101 | 393 | |
| other | Neutropenia | Investigations | Arm II (Carboplatin + Paclitaxel+Placebo) | 117 | 397 | |
| other | Thrombocytopenia | Investigations | Arm I (Carboplatin + Paclitaxel + Sorafenib) | 182 | 393 | |
| other | Thrombocytopenia | Investigations | Arm II (Carboplatin + Paclitaxel+Placebo) | 131 | 397 |
1 to 10 of 430Source ClinicalTrials.gov
See all 430 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Carboplatin + Paclitaxel + Sorafenib) | ||
| Total, all-cause mortality | Arm II (Carboplatin + Paclitaxel+Placebo) | ||
| Total, other adverse events | Arm I (Carboplatin + Paclitaxel + Sorafenib) | 385 | 393 |
| Total, other adverse events | Arm II (Carboplatin + Paclitaxel+Placebo) | 384 | 397 |
| Total, serious adverse events | Arm I (Carboplatin + Paclitaxel + Sorafenib) | 332 | 393 |
| Total, serious adverse events | Arm II (Carboplatin + Paclitaxel+Placebo) | 311 | 397 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23248256 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Carboplatin + Paclitaxel + Sorafenib) vs Arm II (Carboplatin + Paclitaxel+Placebo): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00110019
GET https://conductscience.org/api/trials/v1/NCT00110019/events?page=2