Liposomal Doxorubicin Versus Carboplatin/Paclitaxel in Patients With Ovarian Cancer Recurrence Between 6 and 12 Months After Previous Platinum Based Therapy: Phase III Randomized Multicenter Study Amendment Title Protocol Version 2.0: Phase III International Multicenter Randomized Study Testing the Effect on Survival of Prolonging Platinum-free Interval in Patients With Ovarian Cancer Recurring Between 6 and 12 Months After Previous Platinum Based Chemotherapy.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Sandro Pignata, M.D., Ph.D.
National Cancer Institute, Naples
Italy: Ethics Committee