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Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01143402
First received: June 11, 2010
Last updated: April 7, 2017
Last verified: April 2017
Results First Received: April 7, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Iris Melanoma
Medium/Large Size Posterior Uveal Melanoma
Ocular Melanoma With Extraocular Extension
Recurrent Uveal Melanoma
Small Size Posterior Uveal Melanoma
Stage IV Uveal Melanoma
Interventions: Drug: Dacarbazine
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Drug: Selumetinib
Drug: Temozolomide

  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
No text entered.

Reporting Groups
  Description
Arm I (Temozolomide) Randomized to Temozolomide
Arm II (Selumetinib) Randomized to Selumetinib
Non-Randomized (Selumetinib) Non-Randomized to Selumetinib

Participant Flow:   Overall Study
    Arm I (Temozolomide)   Arm II (Selumetinib)   Non-Randomized (Selumetinib)
STARTED   51   50   19 
COMPLETED   50   49   18 
NOT COMPLETED   1   1   1 
Rapid clinical decline                1                1                0 
Not Treated                0                0                1 



  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 (Temozolomide) Randomized to Temozolomide
Arm II (Selumetinib) Randomized to Selumetinib
Non-Randomized (Selumetinib) Non-Randomized to Selumetinib
Total Total of all reporting groups

Baseline Measures
   Arm I (Temozolomide)   Arm II (Selumetinib)   Non-Randomized (Selumetinib)   Total 
Overall Participants Analyzed 
[Units: Participants]
 51   50   19   120 
Age 
[Units: Years]
Median (Full Range)
 62 
 (34 to 86) 
 62 
 (32 to 86) 
 63 
 (42 to 81) 
 62 
 (32 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      20  39.2%      24  48.0%      10  52.6%      54  45.0% 
Male      31  60.8%      26  52.0%      9  47.4%      66  55.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS) (Evaluable Randomized Patients)   [ Time Frame: The time from randomization to the earlier date of objective disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or death due to any cause in the absence of progression, assessed up to 5 years ]

2.  Secondary:   Median Overall Survival (Evaluable Randomized Patients)   [ Time Frame: The time from randomization to death due to any cause, assessed up to 5 years ]

3.  Other Pre-specified:   Objective Disease Progression   [ Time Frame: assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Other Pre-specified:   Overall Survival   [ Time Frame: The time from randomization to death due to any cause, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Other Pre-specified:   Response Rate (Complete and Partial Response)   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   Toxicity According to the National Cancer Institute Common Toxicity Criteria   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   PFS (Group 3)   [ Time Frame: 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Apoptosis in the Paired Samples, Performed by Caspase 3 Cleavage   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   Change in Ki67   [ Time Frame: Baseline up to 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Other Pre-specified:   Change in p-AKT   [ Time Frame: Baseline up to 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Other Pre-specified:   Change in p-ERK   [ Time Frame: Baseline up to 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Other Pre-specified:   Change in PTEN   [ Time Frame: Baseline up to 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Other Pre-specified:   Changes in Maximum Standardized Uptake Value on FLT-PET Scans   [ Time Frame: Baseline up to 60 minutes post injection ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

14.  Other Pre-specified:   FACT-M Total Score   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  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: Dr. Paul Chapman
Organization: Memorial Sloan Kettering Cancer Center
phone: 646 888 4162
e-mail: chapmanp@mskcc.org


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

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01143402     History of Changes
Other Study ID Numbers: NCI-2011-01411
NCI-2011-01411 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000674866
10-053 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
8443 ( Other Identifier: CTEP )
N01CM00070 ( U.S. NIH Grant/Contract )
N01CM00071 ( U.S. NIH Grant/Contract )
N01CM00099 ( U.S. NIH Grant/Contract )
N01CM00100 ( U.S. NIH Grant/Contract )
N01CM62206 ( U.S. NIH Grant/Contract )
N01CM62208 ( U.S. NIH Grant/Contract )
P30CA008748 ( U.S. NIH Grant/Contract )
U01CA132123 ( U.S. NIH Grant/Contract )
Study First Received: June 11, 2010
Results First Received: April 7, 2017
Last Updated: April 7, 2017