Adjuvant Cetuximab and Chemoradiation in Head and Neck Cancer

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter, open-label, uncontrolled phase II trial evaluates safety and efficacy of post-operative chemoradiation in combination with cetuximab in squamous cell carcinoma of the head and neck.

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

Details

• Lead Sponsor: Heinrich-Heine University, Duesseldorf
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Signed written informed consent;

• Males or females between 18 and 70 years of age;

• Surgically resected squamous cell carcinomas of the hypopharynx, oropharynx, larynx and oral cavity with high risk of locoregional recurrence not more than 6-9 weeks (maximum) ago;

• To be categorized as high risk patients have to fulfil at least one of the following criteria:

• R0 - resection <5 mm margin

• R1 - resection

• Extracapsular nodal extension;

• no previous chemotherapy, radiotherapy;

• Performance status ECOG: 0 - 1;

• Contraception in male and female patients if of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing;

• Adequate renal, liver and hematological functions (within maximum 9 weeks until surgery):

• Adequate bone marrow function: neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 10.0 g/dL

• Adequate liver function: Bilirubin < 2.0 mg/dL, AST, ALT, AP, γ-GT < 3 x ULN

• Adequate renal function: creatinine clearance > =60 ml/min

• No distant metastases;

Exclusion Criteria:

• Nasopharyngeal carcinoma;

• R2 resection;

• Invalid informed consent;

• Performance Status > 1;

• Previous chemotherapy or radiotherapy for carcinoma of the head and neck;

• Prior exposure to EGFR pathway targeting therapy;

• Other serious illness or medical conditions:

• Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4;

• Clinically significantly abnormal electrocardiogram (ECG) or left ventricular ejection fraction (LVEF) below the institutional range of the normal

• Significant neurologic or psychiatric disorders including dementia or seizures;

• Active uncontrolled infection;

• Active disseminated intravascular coagulation;

• Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;

• Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC v3.0) grade 2 or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass;

• Having participated in another therapeutic clinical trial or any investigational agent in the preceding 30 days;

• Known allergic/hypersensitivity reaction to any of the components of the treatment;

• Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding;

• Known drug abuse;

• Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix;

• Legal incapacity or limited legal capacity;

• Sensitivity and incompatibility against 5-Fluorouracil

• Sensitivity and incompatibility against platinum-compounds

• Known incompatibilities >grade 3 towards cetuximab

• expected incompliance of patient (e.g. in case of severe alcohol addiction)

• Dental evaluation: Pre treatment dental care before start of radiochemotherapy (approximately 8 to 10 days lapse-time is needed for complete recovery before initiation of radiation therapy).