Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and effectiveness of treatment with Tarceva (Erlotinib) and RADPLAT (RADiation and intraarterial cisPLATin) for patients with Head and Neck cancer

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

Details

• Lead Sponsor: Southern Illinois University
• Collaborators: Genentech, Inc.; OSI Pharmaceuticals
• Treatments: Cisplatin; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed Stage III-IV disease comprised of T3 or T4 N0-2 lesions of the oral cavity, oropharynx, hypopharynx, and larynx.

• No previous radiation therapy or chemotherapy.

• No evidence of distant metastatic disease.

• Age > 18.

• Karnofsky performance status of > 60 (ECOG 2).

• ANC > 1000, platelets > 100,000, calculated or 24-hour creatinine clearance > 60.

• Study-specific informed consent form.

• Protocol treatment must begin < 8 weeks of diagnostic biopsy.

• Ability to understand and the willingness to sign a written informed consent document.

• Patients with surgically cured secondary malignancy who have been disease free > 5 years are eligible.

Exclusion Criteria:

• Radiologic evidence of bone destruction.

• Previous or concurrent head and neck primaries.

• Prior surgery to study site other than biopsy.

• Patients receiving any other investigational agents.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Pregnant women are excluded from this study because treatments and agents have the potential for teratogenic or abortifacient effects. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

• History of a prior or concomitant malignancy (other than carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin).