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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Merck KGaA
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

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00311857


Contacts
Contact: Daniela Schulz-Ertner, MD +49-6221-56 ext 8201 Daniela.Ertner@med.uni-heidelberg.de
Contact: Stephanie E Combs, MD +49-6221-56 ext 8201 Stephanie.Combs@med.uni-heidelberg.de

Locations
Germany
University of Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Daniela Schulz-Ertner, MD    +49-6221-56 ext 8201    Daniela.Ertner@med.uni-heidelberg.de   
Contact: Stephanie E Combs, MD    +49-6221-56 ext 8201    Stephanie.Combs@med.uni-heidelberg.de   
Principal Investigator: Daniela Schulz-Ertner, MD         
Sub-Investigator: Stephanie E Combs, MD         
Sponsors and Collaborators
Heidelberg University
Merck KGaA
Investigators
Principal Investigator: Daniela Schulz-Ertner, MD Heidelberg University

ClinicalTrials.gov Identifier: NCT00311857     History of Changes
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:
Cetuximab

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Cetuximab
Dacarbazine
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action