Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)
Condition: Cancer of Larynx
MeSH terms: Laryngeal Neoplasms
Intervention: Cisplatin; Cetuximab; 5-Fluorouracil; Docetaxel
Intervention description: 1. Day 1: 100 mg/m2, administered as an i.v. infusion will run over one hour. 2. Day #23: Subjects with a < 50% response (NR) to induction chemotherapy will undergo salvage laryngectomy followed by RT. Cisplatin will be added to radiation for patients whose surgical pathology reveals high-risk features (i.e. extracapsular spread, > 2 positive lymph nodes, perineural invasion, or positive margins). Cisplatin will either be dosed a 100 mg/m2 every 21 days or 40 mg/m2 weekly at the discretion of the prescribing physician.; 1. Cetuximab will be administered at 400 mg/m2 on Day 20 (2 hour administration). 2. Cetuximab will be administered in combination with radiation therapy to those subjects who had a Partial or Complete response after the first cycle of the chemotherapy regimen is administered. The dosage for these administrations is 250 mg/m2 over sixty minutes and it will be administered for six weeks.; 5-FU will be administered 750 mg/m2 in 0.9% normal saline as a 24-hour continuous infusion, days #1-4.; 75 mg/m2 by I.V. over one hour on Day # 1 only
Intervention MeSH terms: Docetaxel; Fluorouracil; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer of Larynx

Summary:

      The purpose of this study is to learn how to identify early which patients will respond to
      chemotherapy plus radiation therapy in order to reduce the number of subjects who require
      surgery (followed by radiation therapy).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have pathologically confirmed, previously untreated, resectable,
             squamous cell carcinoma of the larynx.

          -  Disease must be Stage III or IV.

          -  Tumor must be potentially surgically resectable and curable with conventional surgery
             and radiation therapy.

          -  Patients must undergo pre-treatment endoscopic tumor staging and CT scanning.

          -  ECOG Performance status 0-2

          -  Pre-treatment laboratory criteria:

          -  WBC > or = to 3500/ul, granulocyte > or = to 1500/ul.

          -  Platelet count > or equal to 100,000/ul.

          -  Calculated or measured creatinine clearance > or = to 60 cc/min.

          -  Total Bilirubin < or = to 1.5 X ULN.

          -  AST and ALT < or = to 2.5 X ULN.

          -  Patients must give documented informed consent to participate in this study.

        Exclusion Criteria:

          -  Prior head and neck malignancy or history of other prior non-head and neck malignancy
             within the past 3 years.

          -  Prior head and neck radiation or prior chemotherapy.

          -  Documented evidence of distant metastases.

          -  Active infection.

          -  Pregnancy or lactation. Patients must agree to use adequate contraception (hormonal or
             barrier method of birth control) prior to study entry, for the duration of study
             participation and for 3 months after discontinuing therapy.

          -  Any medical or psychiatric illness which in the opinion of the principal investigator
             would compromise the patients ability to tolerate this treatment.

          -  Patients residing in prison.

          -  Age < 18 years.

          -  Patients with psychiatric/social situations that would limit compliance with study
             requirements are not eligible.

          -  Patients with prior radiation to the head and neck.

          -  Patients with prior anti-epidermal growth-factor receptor antibody therapy or therapy
             with a tyrosine-kinase inhibitor.

          -  Patients with Grade > 2 peripheral neuropathy.

          -  Any history of severe hypersensitivity reaction to docetaxel or other drugs formulated
             with polysorbate 80.