Study Using Pharmacogenetics to Select Treatment for Head and Neck Cancer (PGx-SELECT)
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- Progression-free survival [ Time Frame: 36months ] [ Designated as safety issue: No ]
- Objective response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Quality of Life [ Time Frame: 36 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||June 2013|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
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 Name: Erbitux
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.
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.