Clinical trial NCT01256385
Conditions: Recurrent Hypopharyngeal Squamous Cell Carcinoma Recurrent Laryngeal Squamous Cell Carcinoma Recurrent Laryngeal Verrucous Carcinoma Recurrent Lip and Oral Cavity Squamous Cell Carcinoma Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma Recurrent Oral Cavity Verrucous Carcinoma Recurrent Oropharyngeal Squamous Cell Carcinoma Recurrent Salivary Gland Carcinoma Salivary Gland Squamous Cell Carcinoma Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary Stage IV Hypopharyngeal Squamous Cell Carcinoma Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma Stage IVA Laryngeal Squamous Cell Carcinoma Stage IVA Laryngeal Verrucous Carcinoma Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma Stage IVA Major Salivary Gland Carcinoma Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma Stage IVA Oral Cavity Verrucous Carcinoma Stage IVA Oropharyngeal Squamous Cell Carcinoma Stage IVB Laryngeal Squamous Cell Carcinoma Stage IVB Laryngeal Verrucous Carcinoma Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma Stage IVB Major Salivary Gland Carcinoma Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma Stage IVB Oral Cavity Verrucous Carcinoma Stage IVB Oropharyngeal Squamous Cell Carcinoma Stage IVC Laryngeal Squamous Cell Carcinoma Stage IVC Laryngeal Verrucous Carcinoma Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma Stage IVC Major Salivary Gland Carcinoma Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma Stage IVC Oral Cavity Verrucous Carcinoma Stage IVC Oropharyngeal Squamous Cell Carcinoma Tongue Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-11-01; Completion date: 2013-12-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Patients receive temsirolimus 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 2: 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.
Interventions: intervention 1: Cetuximab intervention 2: Laboratory Biomarker Analysis intervention 3: Temsirolimus
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Given IV

Protocol documents: