Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)

Heidelberg University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Glioblastoma Multiforme

Treatments: Procedure: Radiation therapy; Drug: Cetuximab; Drug: Temozolomide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00311857

Eudract-2005-003911-63

PEI 119/01

Details and patient eligibility

About

GERT is a one-armed single-center phase I/II trial. In a first step, dose-escalation of TMZ from 50 mg/m2 to 75mg/m2 together with radiotherapy and cetuximab will be performed. Should safety be proven, the phase II trial will be initiated with the standard dose of 75mg/m2 of TMZ. Cetuximab will be applied in the standard application dose of 400mg/m2 in week 1, thereafter at a dose of 250mg/m2 weekly. A total of 46 patients will be included into this phase I/II trial.

Primary endpoints are feasibility and toxicity, secondary endpoints are overall and progression-free survival. An interim analysis will be performed after inclusion of 15 patients into the main study. Patients' enrolment will be performed over a period of 2 years. The observation time will end 2 years after inclusion of the last patient.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >= 18 and < 70 years of age
• Karnofsky Performance Score >= 60
• histologically confirmed supratentorial GBM
• interval between primary diagnosis and registration for the study < 4 weeks
• patients will be included according to the incidental gender distribution for patients with GBM of ♀/♂ 2:3
• adequate blood values (not older than 14 days prior to initiation of RCHT)
• neutrophil count (ANC) ≥1500/mm3 or white blood cells (WBC) ≥2000/mm3
• platelets ≥100.000/mm3
• hemoglobin ≥10g/dL
• BUN <1.5 times the upper range
• Total and direct bilirubin <1.5times the upper laboratory limit
• Adequate liver enzymes <3 times the upper laboratory limit
• Life expectancy >12 weeks
• Written informed consent

Exclusion criteria

• refusal of the patients to take part in the study
• previous radiotherapy of the brain or chemotherapy with DTIC or TMZ
• known allergy against extrinsical proteins
• previous chemotherapy or therapy with an EGFR-inhibitor
• Previous antibody therapy
• Patients who have not yet recovered from acute toxicities of prior therapies
• Acute infections requiring systemic application of antibiotics
• Frequent vomiting or a medical condition preventing the oral application of TMZ
• Clinically active kidney- liver or cardiac disease
• Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin)
• HIV
• Pregnant or lactating women
• Participation in another clinical study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)