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

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ClinicalTrials.gov Identifier: NCT00673361
Recruitment Status : Terminated
First Posted : May 7, 2008
Results First Posted : April 26, 2013
Last Update Posted : January 13, 2016
Sponsor:
Collaborator:
Bayer
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
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title "Chemo-Switch" Regimen
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 9
Completed 7
Not Completed 2
Reason Not Completed
Screen Failure             2
Arm/Group Title "Chemo-Switch" Regimen
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants
9
[1]
Measure Description: Subjects age 18+
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
5
  55.6%
Male
4
  44.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  22.2%
White
7
  77.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description Terminated study before accrual goal, no data analysis
Time Frame 3 weeks, 6 weeks, 16 weeks, & 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Terminated Studybefore Accrual Goal
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Hide Description [Not Specified]
Time Frame post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title "Chemo-Switch" Regimen
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
"Chemo-Switch" Regimen
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
"Chemo-Switch" Regimen
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
"Chemo-Switch" Regimen
Affected / at Risk (%)
Total   0/9 (0.00%) 
[Not Specified]
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
ClinicalTrials.gov 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