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

Oropharyngeal Neoplasms Clinical Trial

Official title:

Open Label Randomized Phase II, Multicentre, Pilot Study to Evaluate Safety and Efficacy of the Combination of Cetuximab and Concomitant-Boost Accelerated Radiotherapy Followed or Not by a Complementary Treatment With Cetuximab in Patients With Locally Advanced Oropharynx Squamous Cell Carcinoma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00251381
• Other study ID #: 62202-655
• Status: Recruiting
• Phase: Phase 2
• First received: November 9, 2005
• Last updated: October 25, 2006
• Start date: November 2005
• Est. completion date: November 2009

Study information

• Verified date: October 2006
• Source: Trial Form Support S.L.
• Contact: Jaume Graupera
• Phone: 34 93 185 02 00
• Email: jaume.graupera[@]trialformsupport.com
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Description:

• To determine the 1-year rate of locoregional disease control in the experimental arm, using a control arm to avoid selection bias.

• To determine the 2 and 3 year rate of locoregional disease control.

• To evaluate the safety and toxicity of the combination of cetuximab and concomitant-boost accelerated radiotherapy followed by 12 weeks of complementary treatment with cetuximab. Both acute and chronic toxicity will be assessed.

• To determine specific disease-free survival, event-free survival, disease-specific survival and overall survival

• To determine acute and late toxicity

• To determine EGFR, p53, Ki67, and evaluate its value as a prognostic factor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Oropharyngeal Neoplasms

Intervention

Drug:
• Cetuximab

Locations

Country	Name	City	State
Spain	Centro Oncológico Regional de Galicia	A Coruna	Coruña
Spain	Hospital Germans Tries i Pujol	Badalona	Barcelona
Spain	H. de la Santa Creu I Sant Pau	Barcelona
Spain	H. del Mar / H. de la Esperanza	Barcelona
Spain	H.U. Virgen de la Arrixaca	El Palmar	Murcia
Spain	H. Josep Trueta (ICO)	Girona
Spain	Institut Catala Oncologia: Hospital Duran y Reynals	Hospitalet de Llobregat	Barcelona
Spain	H. G. Doctor Negrín	Las Palmas de Gran Canaria
Spain	Clinica Ruber Internacional	Madrid
Spain	Fundación Jiménez Díaz	Madrid
Spain	H. Gregorio Marañón	Madrid
Spain	H. Ramón y Cajal	Madrid
Spain	Complejo Hospitalario Virgen de la Victoria	Malaga
Spain	H. Carlos Haya	Malaga
Spain	Hospital de Navarra	Pamplona	Navarra
Spain	H. U. de Canarias	Santa Cruz de Tenerife	Sta Cruz de Tenerife
Spain	H.U. de Santiago	Santiago
Spain	H. do Meixoeiro	Vigo

Sponsors (2)

Lead Sponsor	Collaborator
Trial Form Support S.L.	Merck KGaA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year rate of Locoregional Disease Control in the experimental arm, deffined as complete and persistent disappearance of disease in the primary tumour and regional lymph nodes.
Secondary	Toxicity and safety of treatment will be evaluated using the Common Toxicity Criteria (CTC) of the NCI, version 3.0.; and late toxicity from radiotherapy, using RTOG/EORTC Late Radiation Morbidity Scoring Scheme.