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

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.

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Key information

Conditions

Ovarian Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Arkansas Oncology Associates, Little Rock, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TLK286 in Combination with Carboplatin

Drug

Experimental Arm

doxorubicin HCl liposome injection

Drug

Active Comparator

Primary outcomes

Study Objectives

Time frame: Every 8 Weeks

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

Sponsors and collaborators

Lead sponsor

Telik

Industry

Registry information

Official study title

Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Feb 7, 2005
Registry last updated: May 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed