Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme

March 27, 2008 updated by: Pfizer

A Phase III, Randomized, Open-Label Study Of IV Edotecarin Vs Temozolomide Or Carmustine (BCNU) Or Lomustine (CCNU) In Patients With Glioblastoma Multiforme At First Relapse After Alkylator-Based (NEO) Adjuvant Chemotherapy

The purpose of this clinical trial is to study Edotecarin in patients with the brain tumor glioblastoma multiforme (GBM) who have progression or first recurrence following initial treatment with surgery, radiation and chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

118

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Pfizer Investigational Site
  • Australia
      • Clayton, Australia
        • Pfizer Investigational Site
    • New South Wales
      • St. Leonards, New South Wales, Australia
        • Pfizer Investigational Site
    • Victoria
      • East Bentleigh, Victoria, Australia
        • Pfizer Investigational Site
  • Austria
      • Graz, Austria
        • Pfizer Investigational Site
      • Wien, Austria
        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Pfizer Investigational Site
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada
        • Pfizer Investigational Site
  • Croatia
      • Split, Croatia
        • Pfizer Investigational Site
      • Zagreb, Croatia
        • Pfizer Investigational Site
  • Czech Republic
      • Hradec Kralove, Czech Republic
        • Pfizer Investigational Site
      • Praha 5, Czech Republic
        • Pfizer Investigational Site
  • France
      • Lyon, France
        • Pfizer Investigational Site
      • Nantes St. Herblain, France
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany
        • Pfizer Investigational Site
      • Mainz, Germany
        • Pfizer Investigational Site
      • Regensburg, Germany
        • Pfizer Investigational Site
      • Tuebingen, Germany
        • Pfizer Investigational Site
  • India
      • Bangalore, India
        • Pfizer Investigational Site
  • Italy
      • Bologna, Italy
        • Pfizer Investigational Site
      • Padova, Italy
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • Pfizer Investigational Site
  • South Africa
      • Cape Town, South Africa
        • Pfizer Investigational Site
      • Pretoria, South Africa
        • Pfizer Investigational Site
  • Spain
      • Badalona, Spain
        • Pfizer Investigational Site
      • Hospitalet de Llobregat, Spain
        • Pfizer Investigational Site
      • Oviedo, Spain
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States
        • Pfizer Investigational Site
    • Florida
      • Orlando, Florida, United States
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • Pfizer Investigational Site
      • Evanston, Illinois, United States
        • Pfizer Investigational Site
    • Kentucky
      • Edgewood, Kentucky, United States
        • Pfizer Investigational Site
      • Edgweood, Kentucky, United States
        • Pfizer Investigational Site
      • Lexington, Kentucky, United States
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Pfizer Investigational Site
    • New Jersey
      • Edison, New Jersey, United States
        • Pfizer Investigational Site
      • Summit, New Jersey, United States
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have biopsy-proven GBM. First relapse (progression or recurrence) of GBM after surgery (or biopsy) and treatment with radiotherapy (conventional fractionated external beam) and chemotherapy (temozolomide- or nitrosurea-based therapy)
  • Must have past biopsy samples available for central pathology review
  • Must have evidence on Gd-MRI of progressive/recurrent disease
  • Must have measurable disease on Gd-MRI obtained within 14 days prior to start of study treatment
  • Must be at least 18 years of age
  • Must have a Karnofsky Performance Status score of at least 70
  • If being treated with steroids, the steroid dose must be stable or decreasing for 1 week prior to randomization
  • If being treated with anticonvulsants, must have no change in the type of anticonvulsants for 2 weeks prior to randomization
  • All acute toxic effects (except for alopecia) of any prior treatment must have resolved or are no greater than grade 1 (NCI Common Toxicity Criteria, Version 2.0)
  • Baseline laboratory data must be within the following limits: absolute neutrophil count at least 1500; platelets at least 100,000; hemoglobin at least 9.0 g/dL; serum creatinine no greater than 1.5 mg/dL, total serum bilirubin no greater than 1.5 times the upper limit of the normal range; SGOT and SGPT no greater than 2.5 times the upper limit of the normal range; albumin at least 3.0 g/dL, serum or urine pregnancy test (for females of childbearing potential) negative within 7 days prior to start of study treatment
  • At least 6 weeks must have elapsed since completion of prior nitrosurea therapy; at least 4 weeks since completion of prior temozolomide therapy
  • Must have written informed consent
  • Must be able and willing to comply with study procedures
  • Must have received prior treatment with radiotherapy (conventional fractionated external beam) and (neo)adjuvant/concurrent chemotherapy (with a temozolomide- or a nitrosurea-based containing )regimen for GBM

Exclusion Criteria:

  • Must not have received prior treatment (except for surgical debulking) of first relapse (progression or recurrence) of GBM
  • Must not have received prior treatment with another topoisomerase-I inhibitor (e.g. irinotecan, topotecan, rubitecan)
  • Must not have had radiosurgery or radiotherapy within 1 month prior to randomization
  • Must not have had prior brachytherapy or chemotherapy wafer implantation
  • Must not have had prior high-dose chemotherapy with bone marrow or stem cell support
  • Must not receive concomitant treatment with any other investigational agent or anti-cancer treatment during the study
  • Must not be currently enrolled in another therapeutic clinical trial for the treatment of GBM
  • Must not currently (or in the past 5 years) have other malignancies (except for adequately treated basal cell or squamous cell skin cancer or non-invasive cervical cancer)
  • Must not have any of the following in the past 6 months: myocardial infarction (heart attack), severe/unstable angina, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident (stroke), or transient ischemic attack (TIA)
  • Must not have had any of the following in the past 2 months: pulmonary embolus (blood clot in lungs), deep venous thrombosis (blood clot in veins), or other significant thromboembolic event
  • Must not have an ongoing cardiac dysrhythmia (abnormal heart rhythm) of grade 2 or higher (NCI Common Toxicity Criteria, Version 2.0)
  • Must not have known human immunodeficiency virus (HIV) infection
  • Must not be pregnant or breastfeeding. Patients (male and female) must be surgically sterile (or postmenopausal for females) or must agree to use effective contraception during the period of study treatment
  • Must not be inappropriate for entry into the study, in the judgment of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare the overall survival associated with edotecarin versus that associated with temozolomide or BCNU or CCNU for the treatment of patients with GBM at first relapse previously treated with alkylator-based (neo)adjuvant therapy

Secondary Outcome Measures

Outcome Measure
To assess measures of tumor control To evaluate measures of clinical benefit To assess the safety profile of edotecarin To assess the PK profile of edotecarin and the potential for drug interactions between anticonvulsants and edotecarin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

September 12, 2003

First Submitted That Met QC Criteria

September 15, 2003

First Posted (Estimate)

September 16, 2003

Study Record Updates

Last Update Posted (Estimate)

April 1, 2008

Last Update Submitted That Met QC Criteria

March 27, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDOAGL-8725-001
  • A5921009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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