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

NCT00921167 | Completed Phase 2

• 1 other identifier: CRCST-L-0006
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glioblastoma; Astrocytoma

Keywords

Glioblastoma; Astrocytoma; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  6 months, 1 year

Secondary Outcomes (4)

• Objective response rate

  6 weeks, 12 weeks

• Overall survival

  6 months, 1 year

• Disease-control rate

  6 weeks, 12 weeks

• Adverse event

  3 weeks, 6 weeks, 9 weeks, 12 weeks

Study Arms (1)

Bevacizumab/Irinotecan

EXPERIMENTAL

Drug: Bevacizumab/Irinotecan

Interventions

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

Bevacizumab/Irinotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Research Center for Solid Tumor, Korea: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Glioblastoma; Astrocytoma

Interventions

Bevacizumab; Irinotecan

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2009
• First Posted: June 16, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

KR (1)