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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 study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00110019
First received: May 3, 2005
Last updated: September 28, 2015
Last verified: July 2015
Results First Received: August 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Mucosal Melanoma
Recurrent Melanoma
Stage IIIA Skin Melanoma
Stage IIIB Skin Melanoma
Stage IIIC Skin Melanoma
Stage IV Skin Melanoma
Interventions: Drug: Carboplatin
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Pharmacological Study
Other: Placebo
Drug: Sorafenib Tosylate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was activated on June 23, 2005, and terminated on April 22, 2008 with the final accrual of 823 patients. Most of patients were accrued through Eastern Cooperative Oncology Group (ECOG), Cancer and Leukemia Group B (CALGB), and Southwest Oncology Group (SWOG). Other Clinical Trials Cooperative Groups also participated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Carboplatin+Paclitaxel+Sorafenib) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
Arm II (Carboplatin+Paclitaxel) Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.

Participant Flow:   Overall Study
    Arm I (Carboplatin+Paclitaxel+Sorafenib)   Arm II (Carboplatin+Paclitaxel)
STARTED   410   413 
Eligible   395   398 
Treated   393   397 
COMPLETED   4   0 
NOT COMPLETED   406   413 
Lack of Efficacy                253                285 
Adverse Event                61                40 
Death                13                15 
Withdrawal by Subject                21                9 
alternative therapy                5                1 
complicating disease                1                1 
symptom deterioration                13                16 
Not start protocol therapy                17                16 
other reasons                22                30 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I (Carboplatin+Paclitaxel+Sorafenib) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
Arm II (Carboplatin+Paclitaxel) Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
Total Total of all reporting groups

Baseline Measures
   Arm I (Carboplatin+Paclitaxel+Sorafenib)   Arm II (Carboplatin+Paclitaxel)   Total 
Overall Participants Analyzed 
[Units: Participants]
 410   413   823 
Age 
[Units: Years]
Median (Full Range)
 60 
 (19 to 86) 
 58 
 (18 to 84) 
 59 
 (18 to 86) 
Gender 
[Units: Participants]
     
Female   140   162   302 
Male   270   251   521 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: 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. ]

2.  Secondary:   Progression-free Survival   [ Time Frame: 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. ]

3.  Secondary:   Objective Response (Complete and Partial Response) Rate   [ Time Frame: Tumor response was assessed after every 2 cycles during cycle 1 through 10. After cycle 10, tumor response was assessed after every 3 cycles. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00110019     History of Changes
Other Study ID Numbers: NCI-2012-02978
NCI-2012-02978 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E2603 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
E2603 ( Other Identifier: CTEP )
U10CA180820 ( US NIH Grant/Contract Award Number )
U10CA021115 ( US NIH Grant/Contract Award Number )
Study First Received: May 3, 2005
Results First Received: August 28, 2012
Last Updated: September 28, 2015
Health Authority: United States: Food and Drug Administration