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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
  Purpose

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


Condition Intervention Phase
Glioblastoma
Astrocytoma
Drug: Bevacizumab/Irinotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Clinical Research Center for Solid Tumor, Korea:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: June 2009
Study Completion Date: December 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921167

Locations
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
  More Information

No publications provided

Responsible Party: Clinical Research Center for Solid Tumor, Korea
ClinicalTrials.gov Identifier: NCT00921167     History of Changes
Other Study ID Numbers: CRCST-L-0006
Study First Received: June 13, 2009
Last Updated: December 3, 2013
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Astrocytoma
Glioblastoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Bevacizumab
Irinotecan
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 23, 2014