The aim of this study is to evaluate efficacy and tolerability, and number of positive response to treatment with CAELYX (50 mg/m\^2), administered as monotherapy once per 4 weeks to patients with metastatic epithelial ovarian cancer, resistant to previous platinum therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Caelyx Intravenous, 50 mg/m\^2 (60 minute infusion) on day 1, every 4 weeks, during 6 cycles
Number of Participants With Complete Response
Complete response was defined as complete disappearance of all measurable and assessable disease with no new disease or disease-related symptoms as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
Time frame: 4 weeks after chemotherapy completed
Number of Participants With Partial Response
Required 50 percent or greater decrease in sum of products of all bidimensionally measurable lesions without progression of assessable disease and no new lesions as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
Time frame: 4 weeks after chemotherapy completed
Number of Participants With Stabilization
All other subjects (except complete or partial responders and those with progression \[see prior definitions\]) were classified as stable disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
Time frame: 4 weeks after chemotherapy completed
Number of Participants With Progression
Progressive disease was defined as 25% or greater increase in the size of measurable lesion. The reappearance of any lesion or clear worsening of assessable disease or the appearance of any new lesion was also considered as progressive disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
Time frame: 4 weeks after chemotherapy completed
Mean Time to Positive (Partial) Treatment Response Achievement
Time to the occurence of partial effect achievement as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging. Partial response required a 50 percent or greater decrease in the sum of the products of all bidimensionally measurable lesions without progression of any assessable disease and no new lesions.
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Time frame: from the beginning of study drug administration up to 4 weeks after chemotherapy completed
Median Time to Progression
Median time to the occurence of progression. Progression was defined as 25 percent or greater increase size of measurable lesion. Reappearance of lesion, worsening of assessable disease or appearance new lesions were considered progression as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
Time frame: from the beginning of study drug administration up to 4 weeks after chemotherapy completed
Mean Survival Time During the Study
Mean time to the occurrence of death
Time frame: from the beginning of study drug administration up to 18 months