Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00612339
Recruitment Status : Completed
First Posted : February 11, 2008
Results First Posted : September 10, 2012
Last Update Posted : May 27, 2013
Sponsor:
Collaborators:
Genentech, Inc.
Schering-Plough
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Glioblastoma
Gliosarcoma
Intervention Drug: Avastin and Temozolomide
Enrollment 41
Recruitment Details Subjects were accrued between October 2007 and September 2008 within the clinic at Duke Comprehensive Cancer Center.
Pre-assignment Details  
Arm/Group Title Avastin and Temozolomide
Hide Arm/Group Description Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
Period Title: Overall Study
Started 41
Completed 41
Not Completed 0
Arm/Group Title Avastin and Temozolomide
Hide Arm/Group Description Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
  78.0%
>=65 years
9
  22.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
58.6  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
15
  36.6%
Male
26
  63.4%
1.Primary Outcome
Title Response Rate
Hide Description The proportion of subjects with complete or partial response as determined by a modification of the RANO (Response Assessment in Neuro-Oncology) criteria. A confirmation of response was not required. Complete Response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects
Arm/Group Title Avastin and Temozolomide
Hide Arm/Group Description:
Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
24.4
(12.4 to 40.3)
Time Frame 6 months
Adverse Event Reporting Description CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
 
Arm/Group Title Avastin and Temozolomide
Hide Arm/Group Description Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
All-Cause Mortality
Avastin and Temozolomide
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Avastin and Temozolomide
Affected / at Risk (%)
Total   10/41 (24.39%) 
Cardiac disorders   
Myocardial infarction  1  1/41 (2.44%) 
Gastrointestinal disorders   
ileus  1  1/41 (2.44%) 
Small intestinal perforation  1  1/41 (2.44%) 
Vomiting  1  2/41 (4.88%) 
General disorders   
Death: Disease progression  1  2/41 (4.88%) 
Infections and infestations   
Anorectal infection  1  1/41 (2.44%) 
Injury, poisoning and procedural complications   
Wound dehiscence  1  1/41 (2.44%) 
Investigations   
Neutrophil count decreased  1  1/41 (2.44%) 
Metabolism and nutrition disorders   
Dehydration  1  1/41 (2.44%) 
Hyperglycemia  1  1/41 (2.44%) 
Nervous system disorders   
Seizure  1  1/41 (2.44%) 
Vascular disorders   
Thromboembolic event  1  2/41 (4.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Avastin and Temozolomide
Affected / at Risk (%)
Total   12/41 (29.27%) 
General disorders   
Fatigue  1  3/41 (7.32%) 
Investigations   
Platelet count decreased  1  3/41 (7.32%) 
Nervous system disorders   
Peripheral motor neuropathy  1  6/41 (14.63%) 
Seizure  1  3/41 (7.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Katherine Peters, MD, PhD
Organization: Duke University Medical Center
Phone: 9196846173
EMail: katherine.peters@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00612339    
Other Study ID Numbers: Pro00001022
First Submitted: January 29, 2008
First Posted: February 11, 2008
Results First Submitted: August 9, 2012
Results First Posted: September 10, 2012
Last Update Posted: May 27, 2013