A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas

Phase 2

Completed

• Conditions: Glioblastoma; Astrocytoma
• Interventions: Drug: Bevacizumab/Irinotecan

• Registration Number: NCT00921167
• Lead Sponsor: Clinical Research Center for Solid Tumor, Korea

Brief Summary

To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-13
• Study First Submitted QC: 2009-06-13
• Study First Posted: 2009-06-16
• Primary Completion: 2012-06
• Status Verified: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Histologically diagnosed recurrent anaplastic astrocytoma or recurrent glioblastoma multiforme
• At least 18 years of age
• Performance status of 0 and 1 on the Eastern Cooperative Oncology Group (ECOG) criteria
• One or more measurable disease
• Adequate hematologic (neutrophil count >= 1500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit (UNL)x2.5, bilirubin level =< UNLx1.5, alkaline phosphatase =< UNLx2.5), and renal (creatinine clearance >= 30mL/min)
• Expected life time more than at least 2 months
• A patients who signed the informed consent prior to the participation in the study

Exclusion Criteria

• A pregnant or lactating patient
• A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A premenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
• A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
• A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
• Medically uncontrolled serious heart, lung, neurological, psychological, or metabolic disease
• Uncontrolled serious infection
• Enrollment in other study within 30 days
• Hemorrhage on baseline radiologic examination
• A patient who refused to sign the informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab/Irinotecan	Bevacizumab/Irinotecan	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	6 months, 1 year

Secondary Outcome Measures

Name	Time	Method
Disease-control rate	6 weeks, 12 weeks
Objective response rate	6 weeks, 12 weeks
Overall survival	6 months, 1 year
Adverse event	3 weeks, 6 weeks, 9 weeks, 12 weeks

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of