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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Heidelberg University.
Recruitment status was:  Recruiting
Merck KGaA
Information provided by:
Heidelberg University Identifier:
First received: April 5, 2006
Last updated: September 7, 2006
Last verified: September 2006

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 Intervention Phase
Glioblastoma Multiforme Drug: Cetuximab Drug: Temozolomide Procedure: Radiation therapy Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Toxicity

Secondary Outcome Measures:
  • Overall survival

Estimated Enrollment: 46
Study Start Date: February 2006

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00311857

Contact: Daniela Schulz-Ertner, MD +49-6221-56 ext 8201
Contact: Stephanie E Combs, MD +49-6221-56 ext 8201

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
Principal Investigator: Daniela Schulz-Ertner, MD Heidelberg University
  More Information Identifier: NCT00311857     History of Changes
Other Study ID Numbers: Eudract-2005-003911-63
PEI 119/01
Study First Received: April 5, 2006
Last Updated: September 7, 2006

Keywords provided by Heidelberg University:

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017