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Carboplatin, Paclitaxel, and Bevacizumab With or Without Everolimus in Treating Patients With Metastatic Malignant Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976573
First Posted: September 14, 2009
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
Results First Submitted: January 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Melanoma (Skin)
Interventions: Biological: bevacizumab
Drug: carboplatin
Drug: everolimus
Drug: paclitaxel

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm A (Bevacizumab, Paclitaxel, and Carboplatin) Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus) Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Arm A (Bevacizumab, Paclitaxel, and Carboplatin)   Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)
STARTED   75   74 
COMPLETED   71   71 
NOT COMPLETED   4   3 
Ineligible                0                1 
Cancel prior to receiving treatment                4                2 



  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.
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Reporting Groups
  Description
Arm A (Bevacizumab, Paclitaxel, and Carboplatin) Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus) Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Arm A (Bevacizumab, Paclitaxel, and Carboplatin)   Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   74   149 
Age 
[Units: Years]
Median (Full Range)
 59 
 (26 to 85) 
 58 
 (29 to 81) 
 59 
 (26 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      21  28.0%      33  44.6%      54  36.2% 
Male      54  72.0%      41  55.4%      95  63.8% 
Region of Enrollment 
[Units: Participants]
     
United States   75   74   149 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: Time from randomization to documentation of disease progression or death without documentation of progression;Up to 5 years ]

2.  Secondary:   Toxicity   [ Time Frame: Up to 5 years ]

3.  Secondary:   Confirmed Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria   [ Time Frame: Up to 5 years ]

4.  Secondary:   Overall Survival Time   [ Time Frame: up to 5 years ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert R. McWilliams, MD
Organization: Mayo Clinic
phone: 507/284-8432
e-mail: mcwilliams.robert@mayo.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00976573     History of Changes
Other Study ID Numbers: NCCTG-N0879
NCI-2011-01968 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000654465 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: September 11, 2009
First Posted: September 14, 2009
Results First Submitted: January 17, 2017
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017