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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921167
• Other study ID #: CRCST-L-0006
• Status: Completed
• Phase: Phase 2
• First received: June 13, 2009
• Last updated: December 3, 2013
• Start date: June 2009
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Clinical Research Center for Solid Tumor, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astrocytoma
• Glioblastoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Research Center for Solid Tumor, Korea	Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		6 months, 1 year	No
Secondary	Objective response rate		6 weeks, 12 weeks	No
Secondary	Overall survival		6 months, 1 year	No
Secondary	Disease-control rate		6 weeks, 12 weeks	No
Secondary	Adverse event		3 weeks, 6 weeks, 9 weeks, 12 weeks	Yes