A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00967330
First received: June 16, 2009
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

This 2 arm study will compare the effect of Avastin + irinotecan versus temozolo mide, in combination with conventional involved field radiotherapy, in patients with newly diagnosed glioblastoma and a non-methylated MGMT promoter. Patients w ill be randomized 3:1 to receive Avastin 10mg/kg iv every 2 weeks + irinotecan 1 25mg/m2 iv every 2 weeks, or temozolomide 75mg/m2 po daily during radiotherapy f ollowed by 6 cycles of temozolomide 150-200mg/m2 po daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until disease progression

, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Glioblastoma Multiforme
Drug: bevacizumab [Avastin]
Drug: irinotecan
Drug: temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival; response rate; time to treatment failure [ Time Frame: assessed every 2 weeks, throughout study ] [ Designated as safety issue: No ]
  • Adverse events; laboratory parameters; QOL [ Time Frame: assessed every 2 weeks, throughout study ] [ Designated as safety issue: No ]

Enrollment: 182
Study Start Date: June 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
10mg/kg iv every 2 weeks
Drug: irinotecan
125mg/m2 iv every 2 weeks
Active Comparator: 2 Drug: temozolomide
75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-70 years of age;
  • glioblastoma, confirmed histologically;
  • no previous chemotherapy or radiotherapy for glioblastoma;
  • non-methylated MGMT promoter in the tumor.

Exclusion Criteria:

  • prior systemic treatment for glioblastoma multiforme;
  • prior treatment with Avastin;
  • significant cardiovascular disease;
  • other active malignant disease.
  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 ClinicalTrials.gov identifier: NCT00967330

Locations
Germany
Aachen, Germany, 52074
Berlin, Germany, 13353
Bochum, Germany, 44892
Bonn, Germany, 53127
Chemnitz, Germany, 09113
Dresden, Germany, 01307
Düsseldorf, Germany, 40225
Erfurt, Germany, 99089
Erlangen, Germany, 91054
Frankfurt am Main, Germany, 60528
Freiburg, Germany, 79106
Göttingen, Germany, 37075
Idar-Oberstein, Germany, 55743
Kiel, Germany, 24105
Köln, Germany, 50937
Leipzig, Germany, 04103
Mannheim, Germany, 68167
Marburg, Germany, 35043
Muenchen, Germany, 81377
München, Germany, 81675
Münster, Germany, 48149
Regensburg, Germany, 93053
Tübingen, Germany, 72076
Ulm, Germany, 89081
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00967330     History of Changes
Other Study ID Numbers: ML21965, 2009-010390-21
Study First Received: June 16, 2009
Last Updated: October 13, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Bevacizumab
Irinotecan
Temozolomide
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014