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

Telik

Status and phase: Completed; Phase 3

Conditions: Ovarian Neoplasms

Treatments: Drug: doxorubicin HCl liposome injection; Drug: topotecan hydrochloride for injection; Drug: TLK286 HCl for injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00057720

TLK286.3017

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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