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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Seoul National University Hospital

Information provided by (Responsible Party):

Clinical Research Center for Solid Tumor, Korea

ClinicalTrials.gov Identifier:

NCT00921167

First received: June 13, 2009

Last updated: April 11, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	June 13, 2009
Last Updated Date	April 11, 2013
Start Date ^ICMJE	June 2009
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 13, 2009)	Progression-free survival [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00921167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 13, 2009)	Objective response rate [ Time Frame: 6 weeks, 12 weeks ] [ Designated as safety issue: No ] Overall survival [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ] Disease-control rate [ Time Frame: 6 weeks, 12 weeks ] [ Designated as safety issue: No ] Adverse event [ Time Frame: 3 weeks, 6 weeks, 9 weeks, 12 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas
Official Title ^ICMJE	A Phase II Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Anaplastic Astrocytoma or Recurrent Glioblastoma Multiforme
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Glioblastoma Astrocytoma
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Bevacizumab/Irinotecan Intervention: Drug: Bevacizumab/Irinotecan
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	32
Estimated Completion Date	December 2013
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT00921167
Other Study ID Numbers ^ICMJE	CRCST-L-0006
Has Data Monitoring Committee	No
Responsible Party	Clinical Research Center for Solid Tumor, Korea
Study Sponsor ^ICMJE	Clinical Research Center for Solid Tumor, Korea
Collaborators ^ICMJE	Seoul National University Hospital
Investigators ^ICMJE	Not Provided
Information Provided By	Clinical Research Center for Solid Tumor, Korea
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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