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

Sponsor

Clinical Research Center for Solid Tumor, Korea (Other)

Overall Status

Completed

CT.gov ID

NCT00921167

Collaborator

Seoul National University Hospital (Other)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Astrocytoma	Drug: Bevacizumab/Irinotecan	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Anaplastic Astrocytoma or Recurrent Glioblastoma Multiforme

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bevacizumab/Irinotecan	Drug: Bevacizumab/Irinotecan Bevacizumab 10mg/kg D1 Irinotecan 125mg/m2 D1 (without enzyme-inducing antiepileptic drugs [EIAEDs] or 340mg/m2 for patients on EIAEDs) every 2 weeks

Arm

Intervention/Treatment

Experimental: Bevacizumab/Irinotecan

Drug: Bevacizumab/Irinotecan

Bevacizumab 10mg/kg D1 Irinotecan 125mg/m2 D1 (without enzyme-inducing antiepileptic drugs [EIAEDs] or 340mg/m2 for patients on EIAEDs) every 2 weeks

Outcome Measures

Primary Outcome Measures

Progression-free survival [6 months, 1 year]

Secondary Outcome Measures

Objective response rate [6 weeks, 12 weeks]
Overall survival [6 months, 1 year]
Disease-control rate [6 weeks, 12 weeks]
Adverse event [3 weeks, 6 weeks, 9 weeks, 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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