Induction Chemotherapy Followed by Chemoradiation With Cetuximab in Head and Neck Cancer

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck.

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

Details

• Lead Sponsor: Institute of Oncology Ljubljana
• Treatments: Cetuximab; Cisplatin; Docetaxel; Fluorouracil

Criteria

Inclusion Criteria:

• Squamous cell carcinoma, histologically proven

• Tumour site: oral cavity, oropharynx, hypopharynx or larynx.

• Locally and/or regionally inoperable tumors (UICC TNM stages IVa or IVb) - - without distant metastases (M0-stage)

• Male or female ≥18 years of age

• Expected survival >6 months

• Presence of at least one bidimensionally measurable index lesion

• Effective contraception for both male and female subjects if risk of conception exists

• WHO performance status 0-2

• Laboratory parameters:

hemoglobin ≥100 g/L leukocyte count > 3.5x109/L, absolute neutrophil count ≥ 1.5x109/L platelet count > 100x109/L total bilirubin < 1.25x upper normal limit transaminases (ALT, AST) < 5x upper normal limit creatinine clearance ≥ 55 mls/minute

• Signed written informed consent

Exclusion Criteria:

• Metastatic disease

• Squamous cell carcinoma of the nasopharynx and nasal cavity and paranasal sinuses

• ChT or XRT ineligibility:

Unstable cardiac disease or any other medical condition likely to compromise the safe delivery of ChT or XRT; Clinically evident hearing impairment; Pre-existing motor or sensory neurotoxicity grade ≥ 2 according to the CTCAE v3.0;

• Any kind of previous therapy for SCCHN (excluding diagnostic biopsy)

• Previous administration of EGFR pathway-targeting therapy

• Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy which is not part of the study protocol

• Participation in another clinical trial within 30 days prior to study entry

• Pregnancy or breast feeding

• History of severe acute pulmonary disease

• Any investigational agent within past 30 days

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

• Known drug abuse / severe alcohol abuse

• Legal incapacity or limited legal capacity

• Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent

• Active, uncontrolled infection

• Other medical condition or other therapy that in the opinion of the investigator precludes the safe administration of the planned ChT and XRT