Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval (MITO-8)

• overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  

• progression free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  
• changes in quality of life [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  quality of life is measured at baseline and at 3 months and 6 months after patient begins study
  
  
• number of objective responses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• worst grade toxicity for each patient [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  

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.