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Completed

NCT Number: NCT00921167

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab/Irinotecan

Drug

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 outcomes

  1. Progression-free survival

    Time frame: 6 months, 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Clinical Research Center for Solid Tumor, Korea

Other

Collaborators

  • Seoul National University Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jun 16, 2009
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.