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Sponsored by: |
Rigshospitalet, Denmark |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00817284 |
Significant activity (radiographic response rates of approximately 60%) has recently been demonstrated in phase II studies in patients with relapsed GBM from the combined use of Irinotecan (CPT-11) and bevacizumab. The 6-month progression-free survival rate is 30% and median survival duration is 9 months. The current first line therapy of GBM patients following initial surgical resection/debulking is the concomitant use of cerebral radiotherapy and the orally available alkylating agent temozolomide, followed by temozolomide for 6 months post-radiotherapy. Considering the significant activity of the combination of Bevacizumab + irinotecan in patients with recurrent GBM, and considering the activity of temozolomide in GBM, it is proposed that the combination of Bevacizumab + Temozolomide may also be an active regimen. Bevacizumab + Temozolomide display non-overlapping toxicity clinically and thus their combined use without significant dose-reductions seems rational.
The toxicity from the combined use of the two drugs prior to radiotherapy, as well as the toxicity when administered together with radiotherapy, is evaluated. This study will try to identity whether Bevacizumab and Irinitecan or Bevacizumab and Temozolomide should be the experimental arm in future phase III comparison with standard care with concomitant Temozolomide and radiotherapy.
Condition | Intervention | Phase |
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Glioblastoma Multiforme |
Drug: bevacizumab and Irinotecan and radiotherapy Drug: Bevacizumab and Temozolomide and radiotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Trial With Bevacizumab, Irinotecan and Cerebral Radiotherapy Versus Bevacizumab, Temozolomide and Cerebral Radiotherapy as First Line Treatment for Patients With Glioblastoma Multiforme |
Estimated Enrollment: | 60 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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arm I: Experimental
Bevacizumab + Irinotecan and concomitant radiotherapy
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Drug: bevacizumab and Irinotecan and radiotherapy
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Arm II: Experimental
Bevacizumab and Temozolomide and concomitant radiotherapy
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Drug: Bevacizumab and Temozolomide and radiotherapy
Bevacizumab 10 mg/kg is administered on days 1 and 15. Temozolomide dosing before start concomitant chemoradiotherapy: 150 mg/m2/day on days 1-5 during the first 28 days treatment cycle, then 200 mg/m2/day on the subsequent cycles until radiotherapy. Temozolomide administered concomitantly with the radiotherapy: Temozolomide 75 mg/m2/day for 7 days per week is administered on each day of radiotherapy. After completed chemoradiotherapy, temozolomide is dosed and administered as it was prior to start chemoradiotherapy, i.e. temozolomide 200 mg/m2/day on days 1-5 out of a 28 days schedule, taking into consideration any previous dose-reductions already made. Radiotherapy is delivered during 3rd and 4th cycle of chemotherapy and consists of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily five days per week (Monday to Friday) over a period of six weeks for a total dose of 60 Gy. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Adequate liver, renal and bone-marrow function, determined as:
Fertile men must use condom
Exclusion criteria:
drugs targeted against the VEGF- or EGFR pathway
Contact: Ulrik Lassen, MD, PH.D | +45 35453545 | |
Contact: Kenneth Hofland, MD, PH.D | +45 35453545 |
Denmark | |
Rigshospitalet | Recruiting |
Copenhagen, Denmark | |
Principal Investigator: Ulrik Lassen, MD, PH.D | |
Århus Hospital | Not yet recruiting |
Århus, Denmark | |
Principal Investigator: Henrik Schultz, MD | |
Odense Hospital | Not yet recruiting |
Odense, Denmark | |
Principal Investigator: Steinbjørn Hansen, MD. PH.D |
Responsible Party: | Rigshospitalet ( Ulrik Lassen ) |
Study ID Numbers: | BIBT-01 |
Study First Received: | December 8, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00817284 History of Changes |
Health Authority: | Denmark: Danish Medicines Agency |
Newly diagnosed patients with glioblastoma multiforme. Performance status 0-2. |
Glioblastoma Astrocytoma Irinotecan Bevacizumab Angiogenesis Inhibitors Temozolomide Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Glioblastoma Multiforme Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents Anticonvulsants Neoplasms, Glandular and Epithelial |
Glioblastoma Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Irinotecan Neoplasms, Nerve Tissue Physiological Effects of Drugs Bevacizumab Neoplasms, Germ Cell and Embryonal Therapeutic Uses Growth Inhibitors Glioma Angiogenesis Modulating Agents Alkylating Agents |
Neoplasms by Histologic Type Astrocytoma Growth Substances Enzyme Inhibitors Temozolomide Angiogenesis Inhibitors Pharmacologic Actions Neuroectodermal Tumors Neoplasms Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |