TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations.

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

Details

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

Criteria

Inclusion criteria include:

• Considered platinum refractory or resistant according to standard criteria

• Progressed during or following completion of one second-line treatment with Doxil/Caelyx or Hycamtin

• Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer

• Measurable disease according to RECIST criteria with documented tumor progression

Exclusion criteria include:

• Treatment with second-line chemotherapy other than Doxil/Caelyx or Hycamtin

• History of whole pelvis radiation therapy within 12 months of enrollment

• Clinically significant cardiac disease

• Evidence of gross hematuria at the time of study entry

• Any signs of intestinal obstruction interfering with nutrition at the time of study entry

• Pregnant or lactating women