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

18 Years
Open (Enrolling)
Head and Neck Squamous Cell Cancer

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Trial Information

A Pilot Prospective 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
germline variations at four SNP loci in three genes involved in DNA nucleotide excision
repair (ERCC1, ERCC2, and XRCC1). Patients with 3 to 8 variants will receive cisplatin (Arm
A). Patients with 2 or fewer variants will receive cetuximab (Arm B).

The hypothesis of the study is that prospectively testing patients for variations in DNA
repair enzymes to determine whether to use cisplatin or cetuximab in locally advanced head
and neck squamous cell cancer is feasible.

Inclusion Criteria:

- Biopsy proven squamous cell carcinoma of the head and neck, including the oral
cavity, oropharynx, hypopharynx, or larynx, but not including primary tumors of the
nasopharynx, sinuses, or salivary glands.

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

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

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

- ECOG performance status
- Women of child-bearing potential must have a negative pregnancy test within 30 hours
before initiation of study drug dosing. Female subjects of reproductive potential
must agree to avoid pregnancy throughout the study and for up to 3 months following
discontinuation of study drug. Male subjects must agree to avoid conceiving a child
throughout the study and for up to 3 months following discontinuation of study drug;

- Hemoglobin >/= 8.0 gm/dL

- Absolute neutrophil count >/= 1500

- Platelet count >/= 100,000

- GFR > 50 mL/min calculated by the Cockcroft-Gault equation

- Total bilirubin Gilbert's syndrome

- 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. Patients
with other malignancies are eligible if they have been continuously disease-free for
>/= 3 years prior to screening for this protocol.

- Age of 18 or older

- Ability and willingness to give informed consent

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

Exclusion Criteria:

- 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 acute or uncontrolled infectious
disorder, or myocardial infarction
- Female patients who are pregnant or breast feeding, or adults who are of reproductive
potential and are unwilling to refrain from conceiving a child during study

- Patients unwilling to comply with the protocol, or provide informed consent

- Psychiatric illness that would limit compliance with study requirements

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Feasibility is defined as follows: Patients' genetic test results are returned within 72 hours for at least 16 patients Genetic testing delays treatment initiation for less than 2 patients Fewer than 2 patients withdraw from study after enrollment

Outcome Time Frame:

20 months

Safety Issue:


Principal Investigator

John F Deeken, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University


United States: Institutional Review Board

Study ID:




Start Date:

May 2012

Completion Date:

December 2014

Related Keywords:

  • Head and Neck Squamous Cell Cancer
  • Head and neck cancer
  • genetic testing
  • cisplatin
  • erbitux
  • radiation therapy
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms



Georgetown Lombardi Comprhensive Cancer Center Washington, District of Columbia  20007