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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00068952 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma |
Drug: Edotecarin Drug: Temozolomide Drug: Carmustine (BCNU) Drug: Lomustine (CCNU) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 118 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | March 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States | |
| Pfizer Investigational Site | |
| PHOENIX, Arizona, United States | |
| United States, Arkansas | |
| Pfizer Investigational Site | |
| Little Rock, Arkansas, United States | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Orlando, Florida, United States | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Evanston, Illinois, United States | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Edgewood, Kentucky, United States | |
| Pfizer Investigational Site | |
| Edgweood, Kentucky, United States | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States | |
| United States, New Hampshire | |
| Pfizer Investigational Site | |
| Lebanon, New Hampshire, United States | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Summit, New Jersey, United States | |
| Pfizer Investigational Site | |
| Edison, New Jersey, United States | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Pittsburgh, Pennsylvania, United States | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| Pfizer Investigational Site | |
| DALLAS, Texas, United States | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Charlottesville, Virginia, United States | |
| Australia | |
| Pfizer Investigational Site | |
| Clayton, Australia | |
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| St. Leonards, New South Wales, Australia | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| East Bentleigh, Victoria, Australia | |
| Austria | |
| Pfizer Investigational Site | |
| Wien, Austria | |
| Pfizer Investigational Site | |
| Graz, Austria | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada | |
| Canada, New Brunswick | |
| Pfizer Investigational Site | |
| Moncton, New Brunswick, Canada | |
| Canada, Nova Scotia | |
| Pfizer Investigational Site | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Ottawa, Ontario, Canada | |
| Pfizer Investigational Site | |
| Hamilton, Ontario, Canada | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada | |
| Croatia | |
| Pfizer Investigational Site | |
| Split, Croatia | |
| Pfizer Investigational Site | |
| Zagreb, Croatia | |
| Czech Republic | |
| Pfizer Investigational Site | |
| Hradec Kralove, Czech Republic | |
| Pfizer Investigational Site | |
| Praha 5, Czech Republic | |
| France | |
| Pfizer Investigational Site | |
| Nantes St. Herblain, France | |
| Pfizer Investigational Site | |
| Lyon, France | |
| Germany | |
| Pfizer Investigational Site | |
| Regensburg, Germany | |
| Pfizer Investigational Site | |
| Mainz, Germany | |
| Pfizer Investigational Site | |
| Tuebingen, Germany | |
| Pfizer Investigational Site | |
| Berlin, Germany | |
| India | |
| Pfizer Investigational Site | |
| Bangalore, India | |
| Italy | |
| Pfizer Investigational Site | |
| Bologna, Italy | |
| Pfizer Investigational Site | |
| Padova, Italy | |
| Russian Federation | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation | |
| Singapore | |
| Pfizer Investigational Site | |
| Unknown, Singapore | |
| South Africa | |
| Pfizer Investigational Site | |
| Cape Town, South Africa | |
| Pfizer Investigational Site | |
| Pretoria, South Africa | |
| Spain | |
| Pfizer Investigational Site | |
| Badalona, Spain | |
| Pfizer Investigational Site | |
| Hospitalet de Llobregat, Spain | |
| Pfizer Investigational Site | |
| Oviedo, Spain | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Study ID Numbers: | EDOAGL-8725-001, A5921009 |
| Study First Received: | September 12, 2003 |
| Last Updated: | March 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00068952 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Glioblastoma Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Astrocytoma Antineoplastic Agents Neoplasms, Nerve Tissue Carmustine Lomustine Temozolomide Pharmacologic Actions |
Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Alkylating Agents Neoplasms, Glandular and Epithelial |