Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Cetuximab; Cisplatin; Docetaxel; Fluorouracil

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.