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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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
Show 52 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| ClinicalTrials.gov Identifier: | NCT00068952 History of Changes |
| Other Study ID Numbers: | EDOAGL-8725-001, A5921009 |
| Study First Received: | September 12, 2003 |
| Last Updated: | March 27, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Carmustine Lomustine Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |