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

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

This study has been completed.

Sponsored by:	Telik
Information provided by:	Telik
ClinicalTrials.gov Identifier:	NCT00057720

Purpose

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.

Condition	Intervention	Phase
Ovarian Neoplasms	Drug: TLK286 HCl for injection Drug: topotecan hydrochloride for injection Drug: doxorubicin HCl liposome injection	Phase III

MedlinePlus related topics:

Cancer Ovarian Cancer

ChemIDplus related topics:

Doxorubicin Doxorubicin hydrochloride Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Safety/Efficacy Study

Official Title:	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)]

Further study details as provided by Telik:

Estimated Enrollment:	440
Study Start Date:	April 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057720

Show 324 Study Locations

Sponsors and Collaborators

Telik

More Information

Study ID Numbers:	TLK286.3017
First Received:	April 7, 2003
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00057720
Health Authority:	United States: Food and Drug Administration

Keywords provided by Telik:

ovary

Study placed in the following topic categories:

Genital Diseases, Female

Ovarian cancer

Ovarian Neoplasms

Gonadal Disorders

Genital Neoplasms, Female

Endocrine System Diseases

Urogenital Neoplasms

Endocrinopathy

Ovarian Diseases

Topotecan

Doxorubicin

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Antibiotics, Antineoplastic

Pharmacologic Actions

Adnexal Diseases

ClinicalTrials.gov processed this record on September 05, 2008