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A Two Arm Trial of Axitinib and Carboplatin/Paclitaxel in Melanoma

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ClinicalTrials.gov Identifier: NCT01174238
Recruitment Status : Completed
First Posted : August 3, 2010
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Adil Daud, University of California, San Francisco

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Melanoma
Interventions: Drug: Axitinib
Drug: Carboplatin
Drug: Paclitaxel

  Participant Flow

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
40 patients were consented; two participants were lost to follow-up prior to treatment and hence were not included in any analyses

Reporting Groups
  Description
Axitinib + Carboplatin/Paclitaxel

Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy

Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase

Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.


Participant Flow:   Overall Study
    Axitinib + Carboplatin/Paclitaxel
STARTED   38 
Participants That Underwent FLT-PET Scan   6 
COMPLETED   36 
NOT COMPLETED   2 
Lost to Follow-up                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.
of 40 consented participants, 38 received at least one study treatment

Reporting Groups
  Description
Axitinib+Carboplatin/Paclitaxel, Including FLT-PET Patients

Axitinib: 5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy

Carboplatin: Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase

Paclitaxel: Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.

6 patients in this group received drug treatment and in addition underwent FLT-PET during first treatment cycle.


Baseline Measures
   Axitinib+Carboplatin/Paclitaxel, Including FLT-PET Patients 
Overall Participants Analyzed 
[Units: Participants]
 38 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.8  (10.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12  31.6% 
Male      26  68.4% 
Region of Enrollment 
[Units: Participants]
 
United States   38 


  Outcome Measures

1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: Monthly during study treatment, up to 12 months ]

2.  Secondary:   Optimal Interval Between the End of Axitinib Therapy and Initiation of Chemotherapy   [ Time Frame: Days 1, 14, 17, and 20 of cycle 1 ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline until death or up to 24 months ]

4.  Secondary:   Time to Progression (TTP)   [ Time Frame: within 7 days of odd cycles after cycle 1 for the duration of treatment, up to 12 cycles ]

5.  Secondary:   Increase From Nadir in the Sum of Maximum (18)F-FLT Uptake Values After Treatment Holiday   [ Time Frame: Baseline, Day 14, Day 20 ]


  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
No text entered.


  More Information

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


Results Point of Contact:  
Name/Title: Adil Daud, MD
Organization: University of California, San Francisco
phone: 415-353-7392
e-mail: adaud@medicine.ucsf.edu



Responsible Party: Adil Daud, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01174238     History of Changes
Other Study ID Numbers: 10852
First Submitted: July 28, 2010
First Posted: August 3, 2010
Results First Submitted: February 28, 2018
Results First Posted: June 8, 2018
Last Update Posted: June 8, 2018