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Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory/Ineligible, Advanced, Squamous Cell Carcinoma

This study has been terminated.
(High patient withdrawal rate)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01009203
First received: November 5, 2009
Last updated: July 14, 2015
Last verified: July 2015
Results First Received: June 15, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Squamous Cell Carcinoma
Interventions: Drug: Erlotinib
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
Dates of recruitment period: December, 2009 - March, 2011

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
Erlotinib and Temsirolimus Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.

Participant Flow:   Overall Study
    Erlotinib and Temsirolimus
STARTED   13 
Received Treatment   12 [1] 
COMPLETED   6 
NOT COMPLETED   7 
Withdrawal by Subject                1 
Adverse Event                5 
Treatment-unrelated death                1 
[1] One patient withdrew consent before treatment started.



  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
Erlotinib and Temsirolimus Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.

Baseline Measures
   Erlotinib and Temsirolimus 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Years]
Median (Full Range)
 61.5 
 (45 to 87) 
Gender 
[Units: Participants]
 
Female   1 
Male   12 


  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: 3 years ]

2.  Secondary:   Toxicity Profile   [ Time Frame: 3 years ]

3.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: 3 years ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: 3 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 NOT 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.


Results Point of Contact:  
Name/Title: Julie E. Bauman, MD
Organization: University of Pittsburgh Medical Center
phone: 4126486507
e-mail: baumanje@upmc.edu


Publications of Results:

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01009203     History of Changes
Other Study ID Numbers: INST OSI4641s
OSI4641s ( Other Identifier: Genentech, Inc )
NCI-2011-02948 ( Registry Identifier: NCI Clinical Trials Reporting Program )
Study First Received: November 5, 2009
Results First Received: June 15, 2015
Last Updated: July 14, 2015
Health Authority: United States: Institutional Review Board