Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Docetaxel; Cisplatin; Cetuximab; Carboplatin
Intervention description: 30 mg/m² by intravenous (IV) administration; 30 mg/m² by intravenous (IV) administration; 400 mg/m² by intravenous (IV) administration, thereafter 250 IV; Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
Intervention MeSH terms: Carboplatin; Docetaxel; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Quality of Life

Summary:

      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.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  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
             ended

          -  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
             radiation)

          -  ≥ 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
             required.

          -  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
             baseline.

          -  Ability to understand and the willingness to sign a written informed consent document.

        EXCLUSION CRITERIA

          -  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
             discretion)

          -  Pregnant and/or lactating