Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments cetuximab, cisplatin, intensity-modulated radiation therapy
Phase phase 2
Target EGFR
Sponsor University of Texas Southwestern Medical Center
Start date December 2008
End date December 2016
Trial size 50 participants
Trial identifier NCT00833261, 112008-004, CA 225314, CDR0000632295, SCCC-04308

Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cetuximab, Cisplatin, and Radiation Therapy
cetuximab
cetuximab
cisplatin
cisplatin
intensity-modulated radiation therapy IMRT
IMRT

Primary Outcomes

Measure
crude survival
time frame: one year

Secondary Outcomes

Measure
progression-free survival and local-regional progression
time frame: 1 year
acute and late toxicities
time frame: 6 month
disease progression
time frame: 1 year
Response
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract - Recurrent disease or second primary SCC - Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence) - Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated to ≥ 45 Gy - More than one recurrence allowed provided the first recurrence occurred > 6 months after the completion of prior radiotherapy - Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension) - No signs of carotid exposure - No primary nasopharyngeal or salivary gland tumor - Equivocal pulmonary nodes on chest CT scan allowed provided they are < 1 cm, cannot be safely biopsied, or are negative on PET scan - No distant metastasis PATIENT CHARACTERISTICS: - Karnofsky performance status 70-100% - ANC ≥ 2,000/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) - Bilirubin < 1.5 mg/dL - AST or ALT < 2 times upper limit of normal - Creatinine clearance ≥ 50 mL/min - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded - No active cardiac disease, including any of the following: - Unstable angina - Uncontrolled hypertension - Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty) - Uncontrolled arrhythmia - Congestive heart failure - At least 3 heart-related hospitalizations within the past year - No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year - No concurrent medical illness that would impair patient tolerance to therapy or limit survival - No other invasive malignancy within the past 2 years - No pre-existing peripheral sensory neuropathy ≥ grade 2 - No prior severe infusion reaction to a monoclonal antibody - No prisoners or individuals who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Recovered from prior surgery - Prior cisplatin and cetuximab allowed - At least 6 months since prior radiotherapy or chemotherapy - No prior radiotherapy > 75 Gy - No prior chemotherapy for recurrent head and neck cancer - Prior chemotherapy as a component of the primary treatment allowed - No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer - Patients with a new primary head and neck cancer whose prior primary head and neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy are eligible provided it has been > 6 months since treatment

Additional Information

Official title A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck
Principal investigator Lucien A. Nedzi, MD
Description OBJECTIVES: Primary - To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma of the head and neck. Secondary - To determine the progression-free survival and local-regional progression in these patients. - To identify and estimate the incidence rate of acute and late toxicities associated with this treatment regimen. - To determine the pattern of disease progression in these patients. OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center.