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

Tracking Information
First Received Date ^ICMJE	April 7, 2003
Last Updated Date	January 10, 2008
Start Date ^ICMJE	April 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00057720 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer
Official Title ^ICMJE	Phase 3 Randomized Study of TLK286 (Telcyta) Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-1 (Assessment of Survival In Solid Tumors-1)]
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Safety/Efficacy Study
Condition ^ICMJE	Ovarian Neoplasms
Intervention ^ICMJE	Drug: TLK286 HCl for injection Drug: topotecan hydrochloride for injection Drug: doxorubicin HCl liposome injection
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	440
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Belgium, Brazil, Chile, Czech Republic, Germany, Hungary, Ireland, Netherlands, South Africa, Spain, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00057720
Responsible Party
Study ID Numbers ^ICMJE	TLK286.3017
Study Sponsor ^ICMJE	Telik
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Telik
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP