Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

This study has been terminated.
(Low accrual; target accrual not met)
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01009515
First received: October 14, 2009
Last updated: October 5, 2015
Last verified: October 2015
Results First Received: August 14, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Melanoma
Intervention: Drug: Paclitaxel, carboplatin, 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
Subjects were recruited from sites in the New Mexico Cancer Care Alliance from October, 2009 to March, 2013.

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
Chemotherapy Combination

Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.

Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles


Participant Flow:   Overall Study
    Chemotherapy Combination
STARTED   19 
COMPLETED   16 
NOT COMPLETED   3 
Withdrawal by Subject                3 



  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
Chemotherapy Combination

Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.

Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles


Baseline Measures
   Chemotherapy Combination 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   12 
>=65 years   7 
Gender 
[Units: Participants]
 
Female   6 
Male   13 
Race/Ethnicity, Customized 
[Units: Participants]
 
White non-Hispanic   14 
White Hispanic   4 
Black   1 
Region of Enrollment 
[Units: Participants]
 
United States   19 
Site of Metastasis 
[Units: Participants]
 
Brain   1 
Bone   8 
Liver   7 
Lung   14 
Other visceral organs   12 
Regional Lymph Nodes   10 
Previous Therapy 
[Units: Participants]
 
Surgery   16 
Radiation   8 
Chemotherapy   4 
Interferon   5 
Immune Vaccines   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: 6 months ]

2.  Secondary:   Overall Survival   [ Time Frame: 2 years ]

3.  Secondary:   Safety Profile   [ Time Frame: Up to 30 days after last on-study treatment, for up to 2 years ]

4.  Secondary:   Time to Progression   [ Time Frame: 2 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: Montaser Shaheen, MD, PhD
Organization: University of New Mexico
phone: 505-925-0404
e-mail: MoShaheen@salud.unm.edu



Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01009515     History of Changes
Other Study ID Numbers: INST 0903
NCI-2011-01939 ( Registry Identifier: NCI CTRP )
Study First Received: October 14, 2009
Results First Received: August 14, 2015
Last Updated: October 5, 2015
Health Authority: United States: Institutional Review Board