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

NCT ID: NCT00311857

Last Updated: 2006-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28

Brief Summary

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.

Conditions

Glioblastoma Multiforme

Keywords

Cetuximab

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cetuximab

Intervention Type: DRUG

Temozolomide

Intervention Type: DRUG

Radiation therapy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Principal Investigators

Daniela Schulz-Ertner, MD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Daniela Schulz-Ertner, MD

Role: CONTACT

Phone: +49-6221-56

Email: Daniela.Ertner@med.uni-heidelberg.de

Stephanie E Combs, MD

Role: CONTACT

Phone: +49-6221-56

Email: Stephanie.Combs@med.uni-heidelberg.de

Facility Contacts

Daniela Schulz-Ertner, MD

Role: primary

Stephanie E Combs, MD

Role: backup

Other Identifiers

PEI 119/01

Identifier Type: -

Identifier Source: secondary_id

Eudract-2005-003911-63

Identifier Type: -

Identifier Source: org_study_id