Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory/Ineligible, Advanced, Squamous Cell Carcinoma
|ClinicalTrials.gov Identifier: NCT01009203|
Recruitment Status : Terminated (High patient withdrawal rate)
First Posted : November 6, 2009
Results First Posted : August 10, 2015
Last Update Posted : August 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma||Drug: Erlotinib Drug: Temsirolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory or -Ineligible, Advanced, Squamous Cell Carcinoma of the Head and Neck|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Temsirolimus and Erlotinib
Erlotinib (Tarceva) at 150 mg by mouth daily + Temsirolimus (Torisel) at 15 mg intravenously weekly. Each cycle is comprised of 28 days
Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of informed consent.
Other Names:Drug: Temsirolimus
In the absence of Grade 3 or higher toxicity, a single, intra-patient dose increase of temsirolims to 20 mg intravenously weekly is permitted after the first 28 day cycle. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of informed consent.
- Progression Free Survival (PFS) [ Time Frame: 3 years ]The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or unequivocal progression of existing non-target lesion, the appearance of new lesions, death due to disease without prior objective documentation of progression, or global deterioration in health status attributable to disease requiring a change in therapy without objective evidence of progression.
- Toxicity Profile [ Time Frame: 3 years ]Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit. Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The number of patients affected by adverse events of grade 3 or higher will be reported.
- Overall Response Rate (ORR) [ Time Frame: 3 years ]Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the sum of the percentages of patients achieving complete and partial responses
- Overall Survival (OS) [ Time Frame: 3 years ]The time from treatment initiation to death by any cause
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009203
|United States, New Mexico|
|University of New Mexico Cancer Center @ Lovelace Medical Center|
|Albuquerque, New Mexico, United States, 87102|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87106|
|Principal Investigator:||Homan Fekrazad, MD||University of New Mexico Cancer Center|