Salivary Gland Squamous Cell Carcinoma Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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