Ovarian Cancer Clinical Trial
Official title:
A Randomised, Placebo-controlled, Trial of Concurrent Cediranib [AZD2171] (With Platinum-based Chemotherapy) and Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian Cancer
The purpose of this study is to assess the safety and efficacy of cediranib in combination with standard chemotherapy, in patients who have relapsed with ovarian, fallopian tube or epithelial cancer, after first line platinum based treatment.
ICON6 is a randomised three-arm, two stage, double-blind, placebo-controlled multicentre
Gynaecologic Cancer InterGroup (GCIG) phase III trial.
All patients will receive 6 cycles of platinum-based chemotherapy. Trial drug will be
administered for up to 18 months from randomisation or until progression, whichever is
sooner. Patients who have not progressed at 18 months from randomisation can continue Trial
Drug until progression, if in the opinion of the clinician and the patient there is
continuing clinical benefit.
Patients in Arm A (the reference arm) will receive a platinum-based chemotherapy regimen plus
a daily oral placebo tablet for the duration of the chemotherapy and up to 18 months from
randomisation or until progression.
Patients in Arm B (concurrent cediranib arm) will also receive a platinum-based chemotherapy
regimen plus daily oral cediranib during chemotherapy only, and then an oral daily placebo
tablet up to 18 months from randomisation or until progression.
Patients in Arm C (concurrent and maintenance cediranib arm) will also receive a
platinum-based chemotherapy regimen plus oral cediranib daily during chemotherapy and then
continued up to 18 months from randomisation or until progression.
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