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Paclitaxel and Carboplatin or Temozolomide in Treating Patients With Stage IV Melanoma

This study has been terminated.
(Slow accrual.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00568451
First received: December 5, 2007
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
Results First Received: November 1, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma (Skin)
Interventions: Drug: carboplatin
Drug: paclitaxel
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
Twelve (12) participants with un-resectable stage IV malignant melanoma were enrolled in the study between June 2006 and November 2008 at Mayo Clinic Rochester.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient canceled participation in the trial prior to starting Temozolomide therapy. This patient was excluded from all analysis.

Reporting Groups
  Description
PC (Previously Treated) Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
PC (Chemo Naive) Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
TMZ (Previously Treated) Previously chemotherapy treated cohorts: Temozolomide (TMZ)
TMZ (Chemo Naive) Chemotherapy-naive cohorts: Temozolomide (TMZ)

Participant Flow:   Overall Study
    PC (Previously Treated)     PC (Chemo Naive)     TMZ (Previously Treated)     TMZ (Chemo Naive)  
STARTED     0     0     2     9  
COMPLETED     0     0     0     2  
NOT COMPLETED     0     0     2     7  
Disease Progression                 0                 0                 2                 7  



  Baseline Characteristics
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Reporting Groups
  Description
PC (Previously Treated) Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
PC (Chemo Naive) Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
TMZ (Previously Treated) Previously chemotherapy treated cohorts: Temozolomide (TMZ)
TMZ (Chemo Naive) Chemotherapy-naive cohorts: Temozolomide (TMZ)
Total Total of all reporting groups

Baseline Measures
    PC (Previously Treated)     PC (Chemo Naive)     TMZ (Previously Treated)     TMZ (Chemo Naive)     Total  
Number of Participants  
[units: participants]
 		  0     0     2     9     11  
Age  
[units: years]
Mean ± Standard Deviation 		          61.5  ± 14.85     63.3  ± 14.05     62.4  ± 12.97  
Gender  
[units: participants]
 		         
Female             0     3     3  
Male             2     6     8  
Region of Enrollment  
[units: participants]
 		         
United States             2     9     11  
M Stage [1]
[units: participants]
 		         
M1a (skin/subcutaneous tissue/lymph node only)             0     1     1  
M1b (lung)             1     3     4  
M1c (other visceral sites)             1     5     6  
Number of Metastatic Sites  
[units: Sites]
Median ( Full Range ) 		   
    		   
    		  2  
  ( 2 to 2 )   		  2  
  ( 1 to 5 )   		  2  
  ( 1 to 5 )  
[1] M stage is based on whether the melanoma has metastasized (spread) to distant organs, which organs it has reached, and on blood levels of a substance called LDH.



  Outcome Measures
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1.  Primary:   Number of Participants With an Objective Tumor Status of Either a Complete Response(CR) or Partial Response (PR), According to RECIST (Response Evaluation Criteria in Solid Tumors) Criteria   [ Time Frame: Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment ]
  Show Outcome Measure 1

2.  Secondary:   Time to Disease Progression   [ Time Frame: up to 2 years ]
  Show Outcome Measure 2

3.  Secondary:   Survival Time   [ Time Frame: up to 2 years ]
  Show Outcome Measure 3

4.  Secondary:   Duration of Response for All Evaluable Patients Who Have Achieved an Objective Response   [ Time Frame: up to 2 years ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants Who Experienced Changes in Immunologic Profile (CD4/CD25+ Cells, CD4/Fox-p3+ T Cells) Within a Treatment   [ Time Frame: up to 2 years ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants Who Experienced Changes in Immunologic Profile (MART-1, Tyrosinase, and gp100) Within a Treatment   [ Time Frame: up to 2 years ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants Who Experienced Changes in Immunologic Profile (IFNγ Producing Peptide Specific CTLs) Within a Treatment   [ Time Frame: up to 2 years ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
This trial was stopped prior to achieving its accrual goals due to slow enrollment rate. Early termination leading to small numbers of subjects analyzed.  


Results Point of Contact:  
Name/Title: Svetomir N. Markovic M.D., Ph.D.
Organization: Mayo Clinic Cancer Center
phone: 507-284-2511 ext 4-2511
e-mail: markovic.svetomir@mayo.edu


No publications provided


Responsible Party: Svetomir Markovic, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00568451     History of Changes
Other Study ID Numbers: CDR0000578996, P30CA015083, MC057F, 06-002547, NCI-2010-01794
Study First Received: December 5, 2007
Results First Received: November 1, 2011
Last Updated: April 11, 2012
Health Authority: United States: Food and Drug Administration