Epithelial Ovarian Cancer Clinical Trial
Official title:
PHASE III RANDOMIZED CONTROL CASE STUDY OF LETROZOLE IN WOMEN WITH HEAVILY PRETREATED OVARIAN CANCER (MITO 32)
Randomized phase III multicenter study investigating the role of letrozole in heavily pretreated recurrent ovarian cancer.
This is a randomized, open-label, phase III, multicenter, global study evaluating the
efficacy and safety of Letrozole in heavily pretreated recurrent ovarian cancer patients in
comparison to physician' choice chemotherapy.
Subjects who meet all the inclusion criteria and none of the exclusion criteria will be
randomized in a 1:1 ratio to one of the two arms, as follow:
Arm A: Letrozole 1 tablet (2,5 mg) orally once a day in 28-day cycles Arm B: Pegylated
Liposomal Doxorubicin 40 mg/m2 d1q28 or Topotecan 4 mg/m2 d1,8,15q28 or Gemcitabine 1000
mg/m2 d1,8,15q28 or Paclitaxel 80 mg/m2 d1,8,15q28 In case of objective response and
acceptable toxicity, no maximum number of cycles of treatment is defined.
The aim of the study is to assess the activity of Letrozole in women with recurrent
epithelial ovarian cancer, heavily pretreated.
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