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

Stopped early · Phase 2

Conditions studied: Cancer of Larynx

In brief

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).

Key facts

Study ID

NCT00599131

Run by

University of Michigan Rogel Cancer Center

People needed

4

Starts

2007-08-01

Expected to finish

2010-10-01

Last updated by the study team

2015-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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