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Spots Global Cancer Trial Database for Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy

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Trial Identification

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

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Tanguy Seiwert

Affiliation: University of Chicago Comprehensive Cancer Center P2C

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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