Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Not Recruiting

Trial ID: NCT01437449


Docetaxel and cetuximab are FDA-approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Cisplatin and carboplatin, while not FDA-approved for SCCHN, have been used as standard of care in SCCHN patients in combination with other drugs. This study evaluates if weekly cisplatin and docetaxel, in combination with cetuximab, is effective in palliative treatment of patients with SCCHN. These drugs will be given intravenously weekly, repeated 3 of every 4 weeks until evidence of disease progression or unacceptable adverse events.

Official Title

Weekly Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With SCCHN

Stanford Investigator(s)

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Harlan Pinto
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)



   - Squamous cell carcinoma (SCC) of head and neck (SCCHN), including all pharynx, larynx,
   oral cavity, skin and para-nasal sinus sites. Patients with SCC of unknown primary
   presenting in the neck clinically compatible with head and neck mucosal primary sites
   are eligible.

   - If prior chemoradiation, radiation, and/or surgery in the potentially curative
   setting, > 3 months has elapsed since the end of the potentially curative treatment

   - If history of other malignancies treated curatively > 1 year prior to enrollment, no
   evidence of relapse at the time of enrollment

   - If brain metastasis, central nervous system (CNS) imaging documents no evidence of CNS
   progression at least 30 days following definitive CNS treatment (resection or

   - ≥ 16 years old

   - Eastern cooperative oncology group (ECOG) Performance Status < 3

   - Laboratory value requirements at enrollment:

   - Absolute neutrophil count > 1500/mm³

   - Platelet count > 100,000/mm³

   - Hemoglobin > 8 g/dL

   - Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) < 2.5 x upper limit
   of normal (ULN) unless liver metastases documented. If so, AST and ALT < 5 x ULN

   - Total bilirubin < 1.5 x ULN, EXCEPT if Gilbert's syndrome is present. If so, total
   bilirubin < 2.5 x ULN

   - Serum Creatinine < 1.5 mg/dL OR an estimated creatinine clearance from 24 hour urine
   collection > 50 mL/min

   - Peripheral neuropathy < grade 2

   - Hearing loss in best ear < grade 2 per Chang criteria if audiogram performed. Formal
   audiology is not required in patients with no clinical evidence of hearing loss at

   - Ability to understand and the willingness to sign a written informed consent document.


   - Prior palliative chemotherapy

   - Active infections including HIV (EXCEPTION: HIV-positive patients on HAART with
   undetectable blood HIV levels, or with history or serological evidence of exposure to
   Hepatitis B without active infection are eligible)

   - Prior grade 3 allergic or infusion reactions to docetaxel, cisplatin or cetuximab
   (EXCEPTION: a history of infusion reactions that were well-tolerated, at physician's

   - Pregnant and/or lactating


drug: Docetaxel

drug: Cisplatin

drug: Cetuximab

drug: Carboplatin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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