Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Drug: Docetaxel
  • Drug: Cisplatin
  • Drug: Cetuximab
  • Drug: Carboplatin

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

16 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
CCTO
650-498-7061
Not Recruiting