Trial Search Results

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

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. Patients treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation of progressive disease and upon meeting eligibility criteria. Anticipated time on study treatment is until disease progression or intolerable toxicity occurs.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Genentech, Inc.

Intervention(s):

  • Drug: MEHD7945A
  • Drug: cetuximab

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting