Study Using Pharmacogenetics to Select Treatment for Head and Neck Cancer (PGx-SELECT)
A Prospective Phase II Clinical Trial to Use Pharmacogenetics (PGx) to Select Erbitux or Cisplatin to Treat Head and Neck Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cetuximab
patients with 2 or fewer genetic variants will receive 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 Names:
|
|
Experimental: Cisplatin
Subjects with 3 to 8 genetic variants will receive 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Progression-free survival
Time Frame: 36months
|
36months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: 36 months
|
36 months
|
|
Quality of Life
Time Frame: 36 months
|
36 months
|
|
Objective response
Time Frame: 36 months
|
36 months
|
|
Toxicity
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Deeken, MD, Georgetown University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PGx-SELECT
- 2008-526
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.