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

This study has been completed.
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: December 3, 2013
Last verified: December 2013

June 13, 2009
December 3, 2013
June 2009
June 2012   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00921167 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas
A Phase II Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Anaplastic Astrocytoma or Recurrent Glioblastoma Multiforme

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glioblastoma
  • Astrocytoma
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
Experimental: Bevacizumab/Irinotecan
Intervention: Drug: Bevacizumab/Irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00921167
CRCST-L-0006
No
Clinical Research Center for Solid Tumor, Korea
Clinical Research Center for Solid Tumor, Korea
Seoul National University Hospital
Not Provided
Clinical Research Center for Solid Tumor, Korea
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP