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

Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) - Phase I/II Trial

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00311857

Enrollment

Registered

2006-04-06

Start date

2006-02-28

Completion date

Unknown

Last updated

2006-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Keywords

Cetuximab

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.

Interventions

DRUGCetuximab

DRUGTemozolomide

PROCEDURERadiation therapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Toxicity	—

Secondary

Measure	Time frame
Overall survival	—

Countries

Germany

Contacts

Primary ContactDaniela Schulz-Ertner, MD

Daniela.Ertner@med.uni-heidelberg.de+49-6221-56

Backup ContactStephanie E Combs, MD

Stephanie.Combs@med.uni-heidelberg.de+49-6221-56

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026