Business reasons

The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy.

This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with liposomal doxorubicin (Doxil/Caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. Patients will be randomly assigned to receive either TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) or active control liposomal doxorubicin (Doxil/Caelyx).

Inclusion Criteria:

• Are a woman 18 years of age or older
• Have histologically or cytologically confirmed epithelial cancer or primary peritoneal cancer
• Have platinum refractory or resistant cancer
• Measurable disease according to radiographic RECIST criteria progression

Exclusion Criteria:

• Had treatment with first-line chemotherapy other than a platinum-containing regimen
• Have clinically significant cardiac disease
• Have any sign of intestinal obstruction interfering with nutrition
• Are pregnant or lactating
• Had prior treatment with liposomal doxorubicin
• Had prior treatment with Telcyta