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

Telik244 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

244

Conditions

Ovarian Neoplasms

Interventions

TLK286 in Combination with CarboplatinDRUG

Experimental Arm

Doxorubicin HCl Liposome InjectionDRUG

Active Comparator

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 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

Locations (222)

Outcomes

Primary Outcomes

Study Objectives

To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin

Time frame: Every 8 Weeks

Data from ClinicalTrials.gov

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Little Rock Hematology Oncology