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Avastin/Temozolomide/Irinotecan for Unresectable/Multifocal Glioblastoma Multiforme

NCT00979017 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2014-03-19

Study results available
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Summary

The primary objective of the study is to determine the efficacy of Avastin in combination with temozolomide and irinotecan in terms of response rate. The secondary objectives are to describe the overall and progression-free survivals of unresectable patients treated with upfront Avastin, temozolomide and irinotecan and to assess the safety of Avastin, temozolomide and irinotecan in unresectable glioblastoma patients.

This is a phase II study with the combination of Avastin, temozolomide and irinotecan for unresectable or multifocal World Health Organization (WHO) grade IV malignant glioma patients. Patients will receive up to four cycles of Avastin, temozolomide and irinotecan. Approximately 41 subjects will take part in this study at Duke.

Conditions

Interventions

DRUG

Avastin

Avastin, by intravenous infusion, 10 mg/kg every 14 days

DRUG

Temozolomide

Oral temozolomide at 200 mg/m2 daily for 5 days

DRUG

Irinotecan

Irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Katy Peters

    lead OTHER

Principal Investigators

  • Katherine B Peters, MD, PhD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-02-28
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00979017 on ClinicalTrials.gov