Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311857
Recruitment Status : Unknown
Verified September 2006 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : April 6, 2006
Last Update Posted : September 8, 2006
Merck KGaA, Darmstadt, Germany
Information provided by:
Heidelberg University

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: Cetuximab Drug: Temozolomide Procedure: Radiation therapy Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) - Phase I/II Trial
Study Start Date : February 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Toxicity

Secondary Outcome Measures :
  1. Overall survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00311857

Layout table for location contacts
Contact: Daniela Schulz-Ertner, MD +49-6221-56 ext 8201
Contact: Stephanie E Combs, MD +49-6221-56 ext 8201

Layout table for location information
University of Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Daniela Schulz-Ertner, MD    +49-6221-56 ext 8201   
Contact: Stephanie E Combs, MD    +49-6221-56 ext 8201   
Principal Investigator: Daniela Schulz-Ertner, MD         
Sub-Investigator: Stephanie E Combs, MD         
Sponsors and Collaborators
Heidelberg University
Merck KGaA, Darmstadt, Germany
Layout table for investigator information
Principal Investigator: Daniela Schulz-Ertner, MD Heidelberg University
Layout table for additonal information Identifier: NCT00311857    
Other Study ID Numbers: Eudract-2005-003911-63
PEI 119/01
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: September 8, 2006
Last Verified: September 2006
Keywords provided by Heidelberg University:
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action