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Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy (MAESTRO HN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01256385
First received: December 7, 2010
Last updated: December 9, 2016
Last verified: December 2016
Results First Received: October 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Laryngeal Verrucous Carcinoma
Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary
Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma
Recurrent Oral Cavity Verrucous Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Recurrent Salivary Gland Carcinoma
Salivary Gland Squamous Cell Carcinoma
Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary
Stage IV Hypopharyngeal Squamous Cell Carcinoma
Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma
Stage IVA Laryngeal Squamous Cell Carcinoma
Stage IVA Laryngeal Verrucous Carcinoma
Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma
Stage IVA Major Salivary Gland Carcinoma
Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage IVA Oral Cavity Verrucous Carcinoma
Stage IVA Oropharyngeal Squamous Cell Carcinoma
Stage IVB Laryngeal Squamous Cell Carcinoma
Stage IVB Laryngeal Verrucous Carcinoma
Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma
Stage IVB Major Salivary Gland Carcinoma
Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage IVB Oral Cavity Verrucous Carcinoma
Stage IVB Oropharyngeal Squamous Cell Carcinoma
Stage IVC Laryngeal Squamous Cell Carcinoma
Stage IVC Laryngeal Verrucous Carcinoma
Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma
Stage IVC Major Salivary Gland Carcinoma
Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage IVC Oral Cavity Verrucous Carcinoma
Stage IVC Oropharyngeal Squamous Cell Carcinoma
Tongue Carcinoma
Interventions: Biological: Cetuximab
Other: Laboratory Biomarker Analysis
Drug: Temsirolimus

  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
No text entered.

Reporting Groups
  Description
Arm A (Cetuximab and Temsirolimus) Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Arm B (Temsirolimus) Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.

Participant Flow:   Overall Study
    Arm A (Cetuximab and Temsirolimus)   Arm B (Temsirolimus)
STARTED   43   43 
Crossover From Arm B to Arm A   0   15 
COMPLETED   40   40 
NOT COMPLETED   3   3 
Physician Decision                1                1 
Withdrawal by Subject                2                2 



  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.
Three patients from each treatment arm did not start treatment and are considered non-evaluable.

Reporting Groups
  Description
Arm A (Cetuximab and Temsirolimus) Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Arm B (Temsirolimus) Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
Total Total of all reporting groups

Baseline Measures
   Arm A (Cetuximab and Temsirolimus)   Arm B (Temsirolimus)   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   80 
Age 
[Units: Years]
Median (Full Range)
 63 
 (48 to 86) 
 63 
 (39 to 81) 
 63 
 (39 to 86) 
Gender 
[Units: Participants]
Count of Participants
     
Female      8  20.0%      3   7.5%      11  13.8% 
Male      32  80.0%      37  92.5%      69  86.3% 
Region of Enrollment 
[Units: Participants]
     
United States   40   40   80 


  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From start of treatment to time of progression or death from any cause, assessed up to 5 years ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 5 years ]

3.  Secondary:   Overall Response Rates (OR)   [ Time Frame: Up to 5 years ]

4.  Secondary:   PFS vs. Historical Control Cohort   [ Time Frame: From start of treatment to time of progression or death of any cause, assessed at 4 months ]

5.  Secondary:   Grade 3 or Higher Hematological Toxicity   [ Time Frame: Up to 5 years ]

6.  Secondary:   Percentage of Responses After Crossover From Control Arm to the Combination Arm, Assessed According to RECIST   [ Time Frame: Up to 5 years ]

7.  Secondary:   PFS of Myofibroblast (+) Cohort   [ Time Frame: From start of treatment to time of progression or death of any cause, assessed up to 5 years ]

8.  Secondary:   Percentage of Responses/Disease Stabilization for Patients Crossing Over to the Combination Therapy After Progressing on Arm B.   [ Time Frame: Up to 5 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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Tanguy Seiwert
Organization: University of Chicago
phone: (773) 702-2452
e-mail: tseiwert@medicine.bsd.uchicago.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01256385     History of Changes
Other Study ID Numbers: NCI-2011-02596
NCI-2011-02596 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000689896
UCCRC-10-428-B
10-428-B
10-428-B ( Other Identifier: University of Chicago Comprehensive Cancer Center P2C )
8692 ( Other Identifier: CTEP )
N01CM00071 ( US NIH Grant/Contract Award Number )
N01CM00099 ( US NIH Grant/Contract Award Number )
N01CM62201 ( US NIH Grant/Contract Award Number )
P30CA014599 ( US NIH Grant/Contract Award Number )
Study First Received: December 7, 2010
Results First Received: October 4, 2016
Last Updated: December 9, 2016