Overview

Cetuximab & Concomitant-Boost Accelerated RT in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.

Status:
Unknown status
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the 1-year rate of locoregional disease control in the experimental arm, using a control arm to avoid selection bias.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Trial Form Support S.L.
Collaborators:
Merck KGaA
Merck KGaA, Darmstadt, Germany
Treatments:
Cetuximab
Criteria
Inclusion Criteria:

- Written informed consent.

- Aged between 18 and 80, inclusive.

- Karnofsky functional status >= 70% at the time of enrolment in study.

- Life expectancy of more than 3 months.

- Histologically confirmed diagnosis of oropharyngeal squamous cell carcinoma: base of
tongue, vallecula, tonsil and tonsillar fossa and pillars, glossotonsillar sulcus,
inferior surface of the soft palate, uvula and lateral and posterior oropharyngeal
wall.

- Stage III or IV with no evidence of distant metastasis (IVA or IV B)

- Patients in medical conditions to receive a radical concomitant-boost accelerated
radiotherapy treatment.

- Neutrophils >= 1500/ mm3, platelet count >= 100 000/ mm3 and haemoglobin >= 10 g/ dL.

- Proper liver function: total bilirubin <= 1.5 x upper limit of normal (ULN); aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN.

- Proper renal function: serum creatinine <= 1.5 x ULN; if the values are > 1.5 x ULN,
creatinine clearance should be >= 55 ml/min.

- Serum calcium within normal limits.

- Adequate nutritional state: weight loss < 20% with respect to usual weight and serum
albumin > 35 g/l.

- Effective birth control method if there is possibility of conception and/or pregnancy.

- Availability of tumour tissue for immunohistochemical analysis of EGFR expression.

Exclusion Criteria:

- Metastatic disease.

- Previous surgical, radiotherapy and/or chemotherapy treatment for the disease in the
study.

- Other non-oropharyngeal tumour sites in the head and neck area.

- Other previous and/or simultaneous squamous cell carcinoma.

- Diagnosis of any other cancer in the previous 5 years, except properly treated
carcinoma in situ of the uterine cervix and/or basal cell skin carcinoma.

- Active infection (infection requiring intravenous antibiotics), including active
tuberculosis and diagnosed HIV.

- Uncontrolled hypertension defined as systolic blood pressure >= 180 mm Hg and/or
diastolic blood pressure >= 130 mm Hg at rest.

- Pregnancy (absence of pregnancy must be confirmed with the serum-HCG test) or
breast-feeding women.

- Chronic, concomitant systemic immunotherapy, or hormonal treatment for the cancer.

- Other concomitant anti-cancer treatments.

- Clinically significant coronary artery disease, history of myocardial infarction in
the previous 12 months or high risk of out of control arrhythmia or cardiac
insufficiency.

- Chronic obstructive pulmonary disease which may have required > 3 hospitalisations in
the previous 12 months.

- Out of control active peptic ulcer.

- Presence of a psychological or medical illness which might impede the patient from
carrying out the study or giving his or her signature on the informed consent

- Known drug abuse (with the exception of excessive alcohol consumption)

- Known allergic reaction to any of the components of the treatment to be studied.

- Previous treatment with monoclonal antibodies or signal transduction inhibitors or
other EGFR-targeted treatment.

- Any experimental treatment in the 30 days prior to enrolment in the study.