TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

This study has been completed.

First Received on January 21, 2003. Last Updated on July 21, 2011 History of Changes

Sponsor:	Telik
Information provided by:	Telik
ClinicalTrials.gov Identifier:	NCT00052065

Purpose

This is a dose-ranging, open-label, Phase 1-2a study of TLK286 in combination with Doxil in patients with platinum refractory or resistant ovarian cancer.

Condition	Intervention	Phase
Ovarian Neoplasms	Drug: TLK286	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Telik:

Estimated Enrollment:	28
Study Start Date:	February 2003
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube cancer or primary peritoneal cancer
Recurrent epithelial ovarian cancer or persistent disease following primary treatment
At least one, but no more than four, prior platinum-containing chemotherapy regimens
At least one prior taxane-containing regimen

Exclusion Criteria

A history of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which the patient has been disease-free for 2 years
Known leptomeningeal metastases or carcinomatous meningitis
Have received prior Doxil or other liposomal doxorubicin
Having received whole pelvis radiation therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052065

Locations

United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Telik

More Information

No publications provided by Telik

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kavanagh JJ, Levenback CF, Ramirez PT, Wolf JL, Moore CL, Jones MR, Meng L, Brown GL, Bast RC Jr. Phase 2 study of canfosfamide in combination with pegylated liposomal doxorubicin in platinum and paclitaxel refractory or resistant epithelial ovarian cancer. J Hematol Oncol. 2010 Mar 11;3:9.

Responsible Party:	Gail Brown, M.D. Chief Medical Officer, Telik, Inc.
ClinicalTrials.gov Identifier:	NCT00052065 History of Changes
Other Study ID Numbers:	TLK286.2011
Study First Received:	January 21, 2003
Last Updated:	July 21, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases

Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on February 09, 2012