Phase II Study With Capecitabine as Monotherapy in the Treatment of Platinum Resistant or Refractory Ovarian Cancer.
Ovarian cancer is the second most frequent and the most deadly gynaecologic cancer.
Standard combination chemotherapy with a platinum derivative (cisplatin or carboplatin) and
a taxane are effective in causing remission in 60 - 80 % of cases, yet recurrences are
frequent and 5-year survival is only 20%. Current therapies for second line treatment of
recurrence in patients who have platinum refractory (who experienced progression of the
disease during first line platinum based therapy) or platinum resistant (who experienced a
recurrence of the disease within 6 months of completing platinum based therapy)ovarian
cancer are limited. Capecitabine, an oral chemotherapy already used in colon and breast
cancers, has shown some promise in early clinical trials for treating recurrent ovarian
Patients entered into this trial will receive oral capecitabine 1250 mg/m2 on days 1-14
every 21 days for up to 6 cycles, depending on response.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
objective response rate
Sandro Pignata, M.D., Ph.D
National Cancer Institute, Naples
Italy: Ethics Committee