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Trial of RAD001 and Erlotinib With Recurrent Head and Neck Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00942734
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Collaborators:
Novartis
OSI Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head And Neck Cancer
Interventions Drug: Erlotinib
Drug: RAD001
Enrollment 49
Recruitment Details Recruitment Period: July 17, 2009 to February 08, 2013. Recruitment was done in various medical clinics in the United States.
Pre-assignment Details Of the forty-nine participants registered, six participants were ineligible and not treated.
Arm/Group Title RAD001 + Erlotinib
Hide Arm/Group Description RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
Period Title: Overall Study
Started 43
Completed 35
Not Completed 8
Reason Not Completed
Adverse Event             2
Protocol Violation             3
Disease Progression             2
Physician Decision             1
Arm/Group Title RAD001 + Erlotinib
Hide Arm/Group Description RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 43 participants
61
(38 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
8
  18.6%
Male
35
  81.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants
43
1.Primary Outcome
Title 12-Week Progression-Free Survival (PFS)
Hide Description Tumor assessments performed by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) after 4 weeks, 12 weeks, then every 8 weeks thereafter. Participants who received at least one dose of RAD001+erlotinib and who die before 12 weeks, counted as having progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progression-free survival defined as stable disease or better. Progressive Disease (PD): >20% increase in sum of LD of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum LD since treatment started.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Eight participants were not evaluable.
Arm/Group Title RAD001 + Erlotinib
Hide Arm/Group Description:
RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Percentage of Participants
48.57
Time Frame Adverse events collected through 12 weeks of treatment (± 3 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RAD001 + Erlotinib
Hide Arm/Group Description RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
All-Cause Mortality
RAD001 + Erlotinib
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
RAD001 + Erlotinib
Affected / at Risk (%) # Events
Total   1/43 (2.33%)    
Metabolism and nutrition disorders   
hypercalcaemia  1  1/43 (2.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RAD001 + Erlotinib
Affected / at Risk (%) # Events
Total   43/43 (100.00%)    
Blood and lymphatic system disorders   
HEMOGLOBIN  1  5/43 (11.63%)  5
LEUKOCYTES  1  2/43 (4.65%)  2
PLATELETS LEVEL  1  5/43 (11.63%)  5
Gastrointestinal disorders   
ANOREXIA  1  3/43 (6.98%)  3
DIARRHEA  1  18/43 (41.86%)  18
DYSPHAGIA  1  2/43 (4.65%)  2
MUCOSITIS  1  18/43 (41.86%)  18
NAUSEA  1  9/43 (20.93%)  9
PAIN (ORAL CAVITY)  1  2/43 (4.65%)  2
VOMITING  1  5/43 (11.63%)  5
General disorders   
DIZZINESS  1  2/43 (4.65%)  2
EDEMA: HEAD AND NECK  1  9/43 (20.93%)  9
EDEMA: LIMB  1  2/43 (4.65%)  2
FATIGUE  1  18/43 (41.86%)  18
WEIGHT LOSS  1  11/43 (25.58%)  11
Investigations   
FEVER WITHOUT NEUTROPINIA  1  2/43 (4.65%)  2
Metabolism and nutrition disorders   
CHOLESTEROL  1  2/43 (4.65%)  2
HYPERGLYCEMIA  1  2/43 (4.65%)  2
HYPERTRIGLYCERIDEMIA  1  3/43 (6.98%)  3
HYPOKALEMIA  1  2/43 (4.65%)  2
Respiratory, thoracic and mediastinal disorders   
DYSPNEA  1  2/43 (4.65%)  2
Skin and subcutaneous tissue disorders   
ACNE  1  27/43 (62.79%)  27
DERMATOLOGY/SKIN  1  5/43 (11.63%)  5
HAND-FOOT SYNDROME  1  2/43 (4.65%)  2
NAIL CHANGES  1  4/43 (9.30%)  4
PRURITUS  1  4/43 (9.30%)  4
RASH/DESQUAMATION  1  5/43 (11.63%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vali Papadimitrakopoulou, MD
Organization: University of Texas (UT) MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00942734    
Other Study ID Numbers: 2008-0567
NCI-2012-01643 ( Registry Identifier: NCI CTRP )
First Submitted: July 20, 2009
First Posted: July 21, 2009
Results First Submitted: November 24, 2015
Results First Posted: February 4, 2016
Last Update Posted: February 4, 2016