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Study Using Pharmacogenetics to Select Treatment for Head and Neck Cancer (PGx-SELECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00881114
Recruitment Status : Withdrawn (Investigator decided it was not feasible to conduct this study)
First Posted : April 15, 2009
Last Update Posted : March 27, 2015
Information provided by:
Georgetown University

Brief Summary:

This is a study for patients with head and neck cancer who will be receiving chemotherapy and radiation therapy for their disease. The purpose of this study is to see if the investigators can use genetic differences between patients to select the right drug to use with radiation therapy. This type of genetic testing is called pharmacogenetics.

Currently there are two drugs used to treat head and neck cancer that have provided a benefit when given with radiation compared to radiation alone in previous studies. These two drugs are cisplatin and cetuximab (Erbitux).

In this trial, the investigators will test whether genetic differences between patients can be used to pick which drug they should receive. A recent study that looked back to see how well patients with head and neck cancer responded to treatment with cisplatin showed that genetic differences in a few genes were associated with who did and who did not survive their cancer. The investigators are taking that finding and using it to test patients for these genetic differences to determine whether they should receive cisplatin or cetuximab. In other words, the investigators are trying to take what is essentially a flip of the coin choice between these two drugs, and instead use individual patient's genetic differences to make-and hopefully improve- this choice.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Cisplatin Drug: Cetuximab Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Phase II Clinical Trial to Use Pharmacogenetics (PGx) to Select Erbitux or Cisplatin to Treat Head and Neck Cancer
Study Start Date : April 2009
Actual Primary Completion Date : June 2009
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cetuximab
patients with 2 or fewer genetic variants will receive cetuximab
Drug: Cetuximab
Intensity modulated Radiation Therapy with concurrent chemotherapy. Cetuximab will be administered beginning at a dose of 400 mg/m2 the week before radiation commences, then at a dose of 250 mg/m2 weekly during weeks 1 to 7. Post treatment neck dissection will be performed if clinically indicated.
Other Name: Erbitux

Experimental: Cisplatin
Subjects with 3 to 8 genetic variants will receive cisplatin
Drug: Cisplatin
Intensity modulated radiation therapy with concurrent chemotherapy. Cisplatin will be administered at a dose of 100 mg/m2 during weeks 1, 4, and 7 of radiation therapy. Post treatment neck dissection will be performed if clinically indicated.
Other Names:
  • cis-diamminedichloridoplatinum(II)
  • CDDP

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 36months ]

Secondary Outcome Measures :
  1. Objective response [ Time Frame: 36 months ]
  2. Overall survival [ Time Frame: 36 months ]
  3. Toxicity [ Time Frame: 8 weeks ]
  4. Quality of Life [ Time Frame: 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 cancer
  • 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 </= 1.5 upper limits of normal
  • AST and ALT </= 2.5 times upper limits of normal
  • 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 protocol

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 </= 6 months prior to study entry
  • Psychiatric illness that would limit compliance with study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00881114

Sponsors and Collaborators
Georgetown University
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Principal Investigator: John Deeken, MD Georgetown University

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Responsible Party: John Deeken, MD, Georgetown University Medical Center Identifier: NCT00881114     History of Changes
Other Study ID Numbers: PGx-SELECT
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: March 27, 2015
Last Verified: April 2009
Keywords provided by Georgetown University:
Head and neck cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Antineoplastic Agents, Immunological