Pilot Trial of "Chemo-Switch" Regimen to Treat Advanced Melanoma

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. Identifier: NCT00673361
Recruitment Status : Terminated
First Posted : May 7, 2008
Results First Posted : April 26, 2013
Last Update Posted : January 13, 2016
Information provided by (Responsible Party):
Duke University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Melanoma
Interventions: Drug: Concurrent decrescendo biochemotherapy regimen
Drug: Low-dose Temozolomide plus Sorafenib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
"Chemo-Switch" Regimen No text entered.

Participant Flow:   Overall Study
    "Chemo-Switch" Regimen
Screen Failure                2 

  Baseline Characteristics

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
"Chemo-Switch" Regimen No text entered.

Baseline Measures
   "Chemo-Switch" Regimen 
Overall Participants Analyzed 
[Units: Participants]
Age, Customized [1] 
[Units: Participants]
[1] Subjects age 18+
[Units: Participants]
Female   5 
Male   4 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   2 
White   7 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
United States   9 

  Outcome Measures

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: 3 weeks, 6 weeks, 16 weeks, & 24 weeks ]

2.  Secondary:   Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria   [ Time Frame: post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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

Results Point of Contact:  
Name/Title: Michael A Morse, M.D.
Organization: Duke University Medical Center
phone: 919-681-3480

Responsible Party: Duke University Identifier: NCT00673361     History of Changes
Other Study ID Numbers: 9361
SR05-888 ( Other Identifier: Legacy Study ID )
First Submitted: May 4, 2008
First Posted: May 7, 2008
Results First Submitted: March 20, 2013
Results First Posted: April 26, 2013
Last Update Posted: January 13, 2016