A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck

Status: Recruiting
Phase:
Diagnosis: Head and Neck Cancer
NCT ID: NCT01577173 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-113

 

This phase II, open-label, randomized study will evaluate the efficacy and safety of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2 weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Anticipated time on study treatment is until disease progression or intolerable toxicity occurs.

 

Conducting Institutions:
Massachusetts General Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Lori Wirth, MD, Massachusetts General Hospital

Site-responsible Investigators:
Guilherme Rabinowits, MD, Dana Farber Cancer Institute

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Rosemary Costello, rcostello@partners.org

Eligibility Criteria

Inclusion Criteria: - Adult patients, >/= 18 years of age - Histologically confirmed Stage III or IV recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) - Progressive disease on or after first-line platinum-based chemotherapy regimen for R/M SCCHN (maximum of 6 cycles) - No more than one platinum-based chemotherapy regimen for R/M SCCHN is allowed - Prior platinum-based treatment as definitive chemo/radiotherapy for locally advanced disease is allowed if completed/terminated >/= 6 months before the platinum-based regimen for R/M SCCHN - Consent to provide archival tumor tissue for biomarker testing - Measurable disease per RECIST v1.1 - ECOG performance status of 0, 1 or 2 - Adequate hematologic, renal and liver function Exclusion Criteria: - Nasopharyngeal cancer - Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members - This includes but is not limited to cetuximab, panitumumab, erlotinib, geftinib, and lapatinib - Prior treatment with an EGFR inhibitor is allowed if it was administered as part of definitive therapy for locally advanced disease and completed >/=1 year before study enrollment - Leptomeningeal disease as the only manifestation of the current malignancy - Active infection requiring iv antibiotics - Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs - Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; bone fractures) - History of heart failure or serious cardiac arrhythmia - History of myocardial infarction within 6 months of Cycle 1, Day 1 - Clinically significant liver disease, including active viral, alcoholic or other hepatitis, cirrhosis, or current alcohol abuse - HIV infection - Primary central nervous system (CNS) malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) - Pregnant or lactating women - Malignancies other than SCCHN within 5 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix
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