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A Prospective Phase II Clinical Trial to Use Pharmacogenetics (PGx) to Select Erbitux or Cisplatin to Treat Head and Neck Cancer

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

A Prospective Phase II Clinical Trial to Use Pharmacogenetics (PGx) to Select Erbitux or Cisplatin to Treat Head and Neck Cancer

Treatment-naive patients with locally advanced, non-metastatic (Stage III to IVB) squamous
cell carcinoma of the head and neck who are candidates for concurrent chemoradiotherapy as
primary therapy with curative intent will be enrolled. Patients will be genotyped for
variations at four SNP loci in 3 genes involved in DNA nucleotide excision repair (ERCC1,
ERCC2, and XRCC1). Patients with 3 to 8 variants will receive cisplatin, while patients with
2 or fewer variants will receive cetuximab.

Inclusion Criteria:

- Biopsy proven squamous cell carcinoma of the head and neck, including of the oral
cavity, oropharynx, hypopharynx, or larynx

- Locally advanced, Stage III or IVB disease and a candidate for primary therapy using
chemotherapy and radiation with curative intent

- Patients with a diagnosis of 'unknown primary' will be eligible if chemoradiotherapy
is primary modality of treatment

- No previous chemotherapy, radiation, or surgery for the diagnosis of head and neck

- ECOG performance status 0 or 1

- Negative pregnancy test

- Hemoglobin >/= 8.0

- Absolute neutrophil count >/= 1500

- Platelet count >/= 100,000

- GFR > 50 mL/min

- Total bilirubin
- AST and ALT
- No other current malignancy, other than basal cell skin cancer, squamous cell skin
cancer, in situ cervical cancer, ductal or lobular in situ of the breast.

- Ability and willingness to give consent

- Subjects must in the opinion of the Investigator be capable of complying with the

Exclusion Criteria:

- Primary tumors of the nasopharynx, sinuses, and salivary glands

- Acute treatment for an infection or other serious medical illness within 14 days
prior to study entry

- Major surgery within 3 weeks prior to study entry

- Known hypersensitivity to cisplatin or cetuximab

- Patients who have any severe or uncontrolled medical conditions or other conditions
that could affect their participation in this study including: unstable angina,
serious uncontrolled cardiac arrhythmia, active or uncontrolled infectious disorder,
myocardial infarction
- Psychiatric illness that would limit compliance with study requirements

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:

Progression-free survival

Outcome Time Frame:


Safety Issue:


Principal Investigator

John Deeken, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University


United States: Institutional Review Board

Study ID:




Start Date:

April 2009

Completion Date:

June 2013

Related Keywords:

  • Head and Neck Cancer
  • Head and neck cancer
  • pharmacogenetics
  • chemoradiotherapy
  • Head and Neck Neoplasms