Treatment Selection According to Skin Reaction to Cetuximab

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The therapy of patients with locally advanced head and neck cancer will be adjusted to the grade of skin rush as recorded after the first two cycles of Cetuximab and Cisplatin, i.e. either with radioimmunotherapy (radiotherapy and Cetuximab) or radiochemotherapy (radiotherapy and Cisplatin.

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

Details

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

Criteria

Inclusion Criteria:

• Squamous cell carcinoma, histologically proven (with HPV-status determined in patients with oropharyngeal primary)

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

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

• Male or female ≥18 years of age

• Expected survival >6 months

• 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 (ECC) ≥ 60 ml/minute;

• Presence of at least one bidimensionally measurable index lesion

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

• Signed written informed consent

Exclusion Criteria:

• 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

• Chemotherapy ineligibility:

unstable cardiopulmonary, renal and liver disease likely to compromise the safe delivery of I.V. infusion (chemotherapy); haematologic diseases; clinically evident hearing impairment; pre-existing motor or sensory neurotoxicity grade ≥ 2 according to the CTCAE v3.0; previous administration of Cetuximab or Cisplatin;

• Active, uncontrolled infection

• Medical or psychological condition which in the opinion of the investigator precludes the safe administration of the planned radiotherapy or systemic therapy

• Known drug abuse or severe alcohol abuse

• Pregnancy or breast feeding