Clinical trial NCT00311857: Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)
Official title: Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) - Phase I/II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Glioblastoma Multiforme
Keywords: Cetuximab
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2006-04-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Toxicity
Secondary outcomes:
measure: Overall survival
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Heidelberg University
name: Daniela Schulz-Ertner, MD
role: PRINCIPAL_INVESTIGATOR
References: