This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative.
Ovarian cancer is the most deadly gynecologic cancer. Though many patients respond well initially to chemotherapy, most of them in time will suffer a relapse. Patients often receive multiple lines of chemotherapy for their recurrences, and the choice of chemotherapy depends largely on the time interval since the last therapy. Patients whose disease recurs longer than 12 months after a platinum containing treatment are considered to be platinum sensitive, and are candidates for retreatment with a platinum regimen. Patients in whom disease recurs less than 6 months after a platinum containing treatment are considered platinum resistant or refractory, and are treated with a non platinum chemotherapy. The option of treatment is less clear for patients whose disease recurs between 6 and 12 months after platinum containing therapy. It is hypothesized that prolonging the interval since last platinum treatment by using a non platinum chemotherapy will result in better outcomes for these patients. This study will evaluate if the experimental sequence of a non platinum based chemotherapy, followed at a later progression by a platinum based chemotherapy is superior, in terms of the effect on overall survival, to the standard inverse sequence of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
215
stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days
carboplatin AUC 5 IV day 1 every 21 days
paclitaxel 175 mg/m2 IV day 1 every 21 days
overall survival
Time frame: 18 months
progression free survival
Time frame: 18 months
changes in quality of life
quality of life is measured at baseline and at 3 months and 6 months after patient begins study
Time frame: 9 months
number of objective responses
Time frame: 6 months
worst grade toxicity for each patient
Time frame: 6 months
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dosing and schedule according to Institutional guidelines
1000 mg/m2 on days 1,8,15 every 28 days
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