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Brief Title: Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
Official Title: 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
Study ID: NCT01256385
Brief Summary: This phase II trial studies how well giving temsirolimus together with cetuximab works compared to temsirolimus alone in treating patients with recurrent and/or metastatic head and neck cancer who did not respond to previous therapy. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving temsirolimus together with cetuximab is more effective than giving temsirolimus alone.
Detailed Description: PRIMARY OBJECTIVES: I. Primary endpoint is progression free survival (PFS) of cetuximab/temsirolimus combination cohort (Arm A) compared to temsirolimus alone (Arm B). SECONDARY OBJECTIVES: 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 A: 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 B: Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A. After completion of study therapy, patients are followed up for a minimum of 8 weeks and then once a year for 5 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Chinese University of Hong Kong-Prince of Wales Hospital, Shatin, Hong Kong, China
Name: Tanguy Seiwert
Affiliation: University of Chicago Comprehensive Cancer Center P2C
Role: PRINCIPAL_INVESTIGATOR