A Study of AT-101 in Combination With Docetaxel in Squamous Cell Carcinoma Of The Head and Neck

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01285635
First received: January 20, 2011
Last updated: June 26, 2015
Last verified: June 2015
Results First Received: January 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Interventions: Drug: AT-101
Drug: Docetaxel

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients will receive arm specific therapy for the first two cycles, then all patients will be switched into the metronomic AT-101 arm for up to 10 cycles.

Reporting Groups
  Description
Docetaxel Then Metronomic AT-101 Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
Pulse AT-101 Then Metronomic AT-101 AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
Metronomic AT-101 Arm AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.

Participant Flow for 2 periods

Period 1:   First Intervention (2 Weeks)
    Docetaxel Then Metronomic AT-101     Pulse AT-101 Then Metronomic AT-101     Metronomic AT-101 Arm  
STARTED     13     11     11  
COMPLETED     13     11     11  
NOT COMPLETED     0     0     0  

Period 2:   Second Intervention (10, 3 Week Cycles)
    Docetaxel Then Metronomic AT-101     Pulse AT-101 Then Metronomic AT-101     Metronomic AT-101 Arm  
STARTED     13     11     11  
COMPLETED     13     11     11  
NOT COMPLETED     0     0     0  



  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
Docetaxel Then Metronomic AT-101 Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
Pulse AT-101 Then Metronomic AT-101 AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles
Metronomic AT-101 Arm AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
Total Total of all reporting groups

Baseline Measures
    Docetaxel Then Metronomic AT-101     Pulse AT-101 Then Metronomic AT-101     Metronomic AT-101 Arm     Total  
Number of Participants  
[units: participants]
  13     11     11     35  
Age  
[units: years]
Mean (Full Range)
  56   (35 to 75)     56   (38 to 67)     59   (41 to 74)     56   (33 to 75)  
Gender  
[units: participants]
       
Female     2     2     2     6  
Male     11     9     9     29  



  Outcome Measures
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1.  Primary:   Number of Patients With a Complete Response (CR) and Partial Response (PR)   [ Time Frame: 12 months ]

2.  Secondary:   Median Overall Survival in Months   [ Time Frame: 3 Years ]

3.  Secondary:   Median Progression Free Survival in Months   [ Time Frame: 3 Years ]

4.  Secondary:   Median Duration of Response   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Measure the Grade III/IV Toxicities for Safety and Tolerability   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Quality of Life Measures   [ Time Frame: see description below ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Dr. Francis Worden, M.D.
Organization: University of Michigan Cancer Center
phone: 734-936-0453
e-mail: fworden@umich.edu


No publications provided


Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01285635     History of Changes
Other Study ID Numbers: UMCC 2010.031, HUM00040432
Study First Received: January 20, 2011
Results First Received: January 20, 2015
Last Updated: June 26, 2015
Health Authority: United States: Food and Drug Administration