Status:
COMPLETED
Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
Lead Sponsor:
Southern Illinois University
Collaborating Sponsors:
Genentech, Inc.
OSI Pharmaceuticals
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Detailed Description
Head and neck malignancies represent a group of epidermoid tumors that arise from the epithelial lining of the mouth, pharynx, and larynx. Three modalities of therapy have established roles in the tre...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00304278
Start Date
March 1 2006
End Date
December 1 2015
Last Update
July 27 2017
Active Locations (1)
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1
Simmons Cooper Cancer Institute/SIU School of Medicine
Springfield, Illinois, United States, 62702