Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer

Phase 3TerminatedNCT00350948

Telik244 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

244

Conditions

Ovarian Neoplasms

Interventions

TelcytaDRUG

Day 1 of 28 day Cycle.

Liposomal DoxorubicinDRUG

Day 1 of 28 Day Cycle. 50 mg/m2

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (71)

Outcomes

Primary Outcomes

To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin

Time frame: Once 244 planned pts. received at least 2 cycles of study treatment(s)

Secondary Outcomes

To evaluate and compare the safety profile of each treatment arm

Time frame: Any patient who received 1 dose of study treatment(s) will be evaluable for safety.

Data from ClinicalTrials.gov

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