Safety Study of Cetuximab, Radiotherapy and Temozolomide... | NCT00311857

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

NCT00311857

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Sep 8, 2006Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Glioblastoma Multiforme

Interventions

Cetuximab
Temozolomide
Radiation therapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PEI 119/01

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 5, 2006

First Submission Date that Met QC Criteria

Apr 5, 2006

First Posted Date

Apr 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2006

Last Update Posted Date

Sep 8, 2006Estimated

Name	Class
Merck KGaA, Darmstadt, Germany	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
Toxicity

Measure	Description	Time Frame
Overall survival

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniela Schulz-Ertner, MD	Contact	+49-6221-56	8201	Daniela.Ertner@med.uni-heidelberg.de
Stephanie E Combs, MD	Contact	+49-6221-56	8201	Stephanie.Combs@med.uni-heidelberg.de

Overall Officials

Name	Affiliation	Role
Daniela Schulz-Ertner, MD	Heidelberg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Heidelberg	Recruiting	Heidelberg	Baden-Wurttemberg	69120	Germany

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

ID	Term
D000068818	Cetuximab
D000077204	Temozolomide
D011878	Radiotherapy

Name	Type	Description	Arm Group Labels	Other Names
Cetuximab	Drug
Temozolomide	Drug
Radiation therapy	Procedure