Efficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644) (COMPLETED)
This study has been completed.
Information provided by:
First received: June 6, 2006
Last updated: September 9, 2008
Last verified: September 2008
The primary purpose of the study is to evaluate the efficacy and safety of temozolomide compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic astrocytoma.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-Label, Randomized, Active-Controlled Parallel Groups Study Comparing the Efficacy and Safety of Temodal vs Semustine in the Treatment of Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma|
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources: Glioblastoma Anaplastic Astrocytoma Glioma NeuroepitheliomaU.S. FDA Resources
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: 2 months, 3 months, and 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Objective response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Scoring of health-related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Study Completion Date:||February 2006|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
Experimental: Temodal group
Subjects treated with temozolomide.
Temozolomide orally for 5 consecutive days (Day 1 through Day 5) every 28 days, at a dose of 150 mg/m2/day for subjects previously treated with chemotherapy, or 200 mg/m2/day for subjects who have not received previous chemotherapy.
Active Comparator: Semustine group
Subjects treated with semustine.
Semustine orally once every 28 days at a dose of 150 mg/m2/day.
Other Name: Methyl-CCNU
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