Ph 3 Randomized Study of Telcyta® + Liposomal Doxorubicin Vs Liposomal Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer

This study is ongoing, but not recruiting participants.

Sponsored by:	Telik
Information provided by:	Telik
ClinicalTrials.gov Identifier:	NCT00350948

Purpose

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.

Condition	Intervention	Phase
Ovarian Neoplasms	Drug: TLK286 (Telcyta) HCI for Injection Drug: Doxorubicin HCI Liposome Injection	Phase III

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)

Further study details as provided by Telik:

Estimated Enrollment:	244
Study Start Date:	May 2006

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350948

Show 71 Study Locations

Sponsors and Collaborators

Telik

More Information

Study ID Numbers:	TLK286.3025
Study First Received:	July 6, 2006
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00350948
Health Authority:	United States: Food and Drug Administration; Belgium: Ministry of Social Affairs, Public Health and the Environment; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Brazil: Ministry of Health

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
Doxorubicin
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses

Antibiotics, Antineoplastic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009