A T1 Translational Multicenter Randomized Phase II Study of Temsirolimus Versus Cetuximab Plus Temsirolimus in Patients With Recurrent / Metastatic Head and Neck Cancer, Who Failed Prior EGFR Based Therapy
I. Primary Endpoint is progression free survival (PFS) of cetuximab/temsirolimus combination
cohort (Arm A) compared to temsirolimus alone (Arm B).
I. Progression-free survival (PFS) of cetuximab/temsirolimus combination group (Arm A) and
temsirolimus control group (Arm B) compared to a historic control cohort.
II. Subgroup analysis of myofibroblast (+) cohort (PFS). III. Overall Survival (OS). IV.
Toxicities. V. Response (Response Evaluation Criteria in Solid Tumors [RECIST])/absolute
tumor shrinkage (waterfall plot analysis).
VI. Activity of combination therapy (temsirolimus/cetuximab) after failure (progressive
disease [PD]) of temsirolimus monotherapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive temsirolimus intravenously (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 II: Patients receive temsirolimus as in arm I. Courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity. Patients with progressive disease
may cross over to arm I.
After completion of study therapy, patients are followed up for a minimum of 8 weeks and
then once a year for 5 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PFS, evaluated using new international criteria proposed by RECIST
PFS of patients treated using temsirolimus with (Arm I) or without (Arm II) cetuximab will be compared.
From start of treatment to time of progression or death of any cause, assessed up to 5 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|Johns Hopkins University||Baltimore, Maryland 21205|
|Mayo Clinic||Rochester, Minnesota 55905|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Loyola University Medical Center||Maywood, Illinois 60153|
|Ingalls Memorial Hospital||Harvey, Illinois 60426|
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Mayo Clinic in Arizona||Scottsdale, Arizona 85259-5404|
|Mayo Clinic in Florida||Jacksonville, Florida 32224|
|Northwestern University||Chicago, Illinois 60611|
|Indiana University Medical Center||Indianapolis, Indiana 46202|
|Metro-Minnesota CCOP||St. Louis Park, Minnesota|
|Decatur Memorial Hospital||Decatur, Illinois 62526|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|Froedtert and the Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Evanston CCOP-NorthShore University HealthSystem||Evanston, Illinois 60201|
|Illinois CancerCare-Peoria||Peoria, Illinois 61615|
|Fort Wayne Medical Oncology and Hematology Inc - State Boulevard||Fort Wayne, Indiana 46845|
|Saint John's Mercy Medical Center||Saint Louis, Missouri 63141|
|University of Maryland Greenebaum Cancer Center||Baltimore, Maryland 21201|
|University of Colorado Cancer Center - Anschutz Cancer Pavilion||Aurora, Colorado 80045|
|University of Michigan University Hospital||Ann Arbor, Michigan 48109|
|Southern Illinois University||Springfield, Illinois 62702|