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

Telik

Status and phase: Completed; Phase 3

Conditions: Ovarian Neoplasms

Treatments: Drug: TLK286 in Combination with Carboplatin; Drug: Doxorubicin HCl Liposome Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00102973

TLK286.3024

Details and patient eligibility

About

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.

Enrollment: 244 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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244 participants in 2 patient groups

TLK286 in Combination with Carboplatin

Experimental group

Treatment:

Drug: TLK286 in Combination with Carboplatin

Doxorubisin HCl Liposome Injection

Active Comparator group

Treatment:

Drug: Doxorubicin HCl Liposome Injection