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

Phase 2
16 Years
Open (Enrolling)
Head and Neck Cancer

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Trial Information

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

Inclusion Criteria:

- Squamous cell carcinoma of head and neck sites, 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.

- Patients who have received prior chemoradiation, radiation, and/ or surgery in the
potentially curative setting are eligible as long as 3 months has elapsed since the
end of the potentially curative treatment ended.

- Patients must be greater than 16 years old.

- ECOG Performance Status < 3 at enrollment is required.

- Laboratory value requirements at enrollment:

- Absolute neutrophil count > 1500/mm3

- Platelet count >100K/mm3

- Hemoglobin > 8 g/dL

- AST and ALT < 2.5 x ULN unless liver metastases documented. In this latter case,
AST and ALT < 5 x ULN required.

- Total Bilirubin < 1.5 x ULN unless the patient has Gilbert's syndrome, in which
case T. Bilirubin < 2.5 x ULN required

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

- Clinical requirements at enrollment:

- Peripheral neuropathy < grade 2

- Hearing loss in best ear < grade 2 per Chang criteria if audiogram performed.
*24 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

Exclusion Criteria:

- No prior palliative chemotherapy

- Patients with active infections including HIV are not eligible. HIV positive patients
on HAART with undetectable blood HIV levels are eligible. Patients with a history or
serological evidence of exposure to Hepatitis B without active infection are eligible
for this study.

- Patients with prior grade 3 allergic or infusion reactions to docetaxel, cisplatin or
cetuximab are not eligible. A history of well tolerated infusion reactions is NOT an

- Pregnant women and/or nursing patients will be excluded from the study because of
potential harm to the fetus or nursing infant.

- Because the primary endpoint of this study is response rate and not survival,
patients with a history of other malignancies treated curatively greater than one
year prior to enrollment and without evidence of relapse at the time of enrollment
are eligible.

- Patients with brain metastasis are eligible only if by CNS imaging there is no
evidence of CNS progression at least 30 days following definitive CNS treatment
(resection or radiation).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

A. Dimitrious Colevas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

October 2011

Completion Date:

December 2014

Related Keywords:

  • Head and Neck Cancer
  • Quality of Life
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



Stanford University Cancer Institute Stanford, California  94305