TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this research study is to determine if TLK286 given in combination with carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is refractory or resistant to platinum chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Telik
• Treatments: Carboplatin; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Are a woman 18 years of age or older

• Have histologically or cytologically confirmed epithelial cancer of the ovary or fallopian tube, or primary peritoneal cancer

• Have platinum refractory or resistant cancer

• Measurable disease according to radiographic RECIST criteria with documented tumor progression

Exclusion Criteria:

• Had treatment with first-line chemotherapy other than platinum-based regimens (carboplatin or cisplatin)

• Have clinically significant cardiac disease

• Have any sign of intestinal obstruction interfering with nutrition at the time of study entry

• Are pregnant or lactating

• Had prior treatment with liposomal doxorubicin for ovarian cancer

• Had prior treatment with TLK286