Trial of RAD001 and Erlotinib With Recurrent Head and Neck Squamous Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00942734|
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Head And Neck Cancer||Drug: Erlotinib Drug: RAD001||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Trial of the Combination of RAD001 and Erlotinib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Experimental: RAD001 + Erlotinib
RAD001 1 tablet (5 mg) by mouth every day of each 28 day study cycle. Erlotinib one tablet (150 mg) by mouth every day of each 28 day study cycle.
One tablet (150 mg) by mouth every day of each 28 day study cycle.
1 tablet (5 mg) by mouth every day of each 28 day study cycle.
Other Name: Everolimus
- 12-Week Progression-Free Survival (PFS) [ Time Frame: 12 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942734
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Vali Papadimitrakopoulou, MD||M.D. Anderson Cancer Center|