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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00921167
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : December 4, 2013
Seoul National University Hospital
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Glioblastoma Astrocytoma Drug: Bevacizumab/Irinotecan Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : December 2013

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

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 6 months, 1 year ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 6 weeks, 12 weeks ]
  2. Overall survival [ Time Frame: 6 months, 1 year ]
  3. Disease-control rate [ Time Frame: 6 weeks, 12 weeks ]
  4. Adverse event [ Time Frame: 3 weeks, 6 weeks, 9 weeks, 12 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00921167

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Clinical Research Center for Solid Tumor, Korea
Seoul National University Hospital

Responsible Party: Clinical Research Center for Solid Tumor, Korea Identifier: NCT00921167     History of Changes
Other Study ID Numbers: CRCST-L-0006
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Keywords provided by Clinical Research Center for Solid Tumor, Korea:

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action