Avastin in Combination With Radiation (XRT) & Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma (GBM) and Gliosarcomas
|ClinicalTrials.gov Identifier: NCT00597402|
Recruitment Status : Completed
First Posted : January 18, 2008
Results First Posted : January 18, 2013
Last Update Posted : May 7, 2014
Primary objective: To use overall survival to assess the efficacy of the combination of radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan in the treatment of grade IV malignant glioma patients following surgical resection.
Secondary objective: To determine the progression-free survival following the combination of radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan.
Exploratory Objective: To explore the relationship between biomarkers and outcome (overall survival and progression-free survival) among patients with grade IV malignant glioma treated with radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan.
To describe the toxicity of radiation therapy,temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Gliosarcoma Brain Tumor||Drug: Avastin Drug: Temozolomide Radiation: Radiation Therapy (XRT) Drug: Irinotecan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Avastin in Combination With Radiation and Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma Multiformes and Gliosarcomas|
|Study Start Date :||July 2007|
|Primary Completion Date :||August 2011|
|Study Completion Date :||May 2013|
|Experimental: Avastin, radiation, temozolomide, and irinotecan||
Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury. Following completion of XRT, patients will receive treatment that includes 6 cycles of Avastin, beginning a minimum of 14 days after last XRT.
Other Name: BevacizumabDrug: Temozolomide
Daily temozolomide 75 mg/m2/day for 6.5 weeks of radiation treatment. Following completion of XRT, patients will receive treatment including temozolomide 200 mg/m2/day on the 1st 5 days of each 28-day cycle.
Other Name: TemodarRadiation: Radiation Therapy (XRT)
Treatment with standard XRT (radiation) for 6.5 weeks.Drug: Irinotecan
Following completion of XRT, patients will receive 6 cycles of treatment that includes irinotecan. Beginning a minimum of 14 days after last XRT, the irinotecan dose will depend on whether the patient is on enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED: 125 mg/m2.)
- 16-month Overall Survival (OS) [ Time Frame: 16 months ]Percentage of participants surviving sixteen months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of death due to any cause.
- 12-month Progression-free Survival (PFS) [ Time Frame: 12 months ]Percentage of participants surviving twelve months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.
- Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage [ Time Frame: 55 months ]Number of times a CNS hemorrhage or systemic hemorrhage was experienced
- Number of Patients Experiencing a Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity [ Time Frame: 55 months ]Number of times a grade ≥ 4 hematologic or grade ≥ 3 non-hematologic toxicity was experienced
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597402
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Annick Desjardins, MD, FRCPC||Duke University Health System|