Glioblastoma Clinical Trial
Official title:
Multi-Center, Randomized, Double-Blind Phase II Study Comparing Cediranib (AZD2171) Plus Gefitinib (Iressa, ZD1839) With Cediranib Plus Placebo in Subjects With Recurrent/Progressive Glioblastoma (DORIC Trial)
RATIONALE: Cediranib Maleate and gefitinib may stop the growth of tumor cells by blocking
some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is
not yet known whether cediranib maleate given together with gefitinib is more effective than
cediranib maleate given alone in treating patients with recurrent or progressive
glioblastoma.
PURPOSE: This randomized phase II trial is studying the side effects of giving cediranib
maleate together with gefitinib and to see how well it works compared with giving cediranib
maleate together with a placebo in treating patients with recurrent or progressive
glioblastoma.
OBJECTIVES:
- To compare progression-free survival, overall survival, radiological response, and
safety and tolerability of cediranib maleate in combination with gefitinib versus
cediranib maleate in combination with a placebo in patients with recurrent or
progressive glioblastoma following standard front-line treatment.
OUTLINE: This is a multicenter study.
Patients receive cediranib maleate and gefitinib or cediranib maleate and a placebo once
daily on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or
unacceptable toxicity.
Blood and tissue samples are collected from some patients for genetic profiling and
biomarker analysis.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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