TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer

This study has been completed.

First Received: January 17, 2003 Last Updated: January 10, 2008 History of Changes

Sponsored by:	Telik
Information provided by:	Telik
ClinicalTrials.gov Identifier:	NCT00051948

Purpose

This is a dose-ranging, open label, Phase 1-2a study of TLK286 in combination with Paraplatin (carboplatin) in patients with recurrent ovarian cancer.

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

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer

Further study details as provided by Telik:

Estimated Enrollment:	28
Study Start Date:	December 2002

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, or primary peritoneal cancer
Recurrent ovarian cancer or persistent disease following primary treatment
At least one, but no more than four, prior chemotherapy regimens (all platinum-containing counted as one)
At least 18 years of age

Exclusion Criteria

Pregnant or lactating women
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 patient has been disease-free for at least 2 years
Known leptomeningeal metastases or carcinomatous meningitis
Having received whole pelvis radiation therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051948

Locations

United States, California
Santa Monica Hematology/Oncology Consultants
Santa Monica, California, United States, 90404
United States, Illinois
Midwest Cancer Research Group, Inc.
Skokie, Illinois, United States, 60077
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Telik

More Information

No publications provided

Study ID Numbers:	TLK286.2018
Study First Received:	January 17, 2003
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00051948 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Ovarian Cancer
Endocrine System Diseases

Urogenital Neoplasms
Carboplatin
Endocrinopathy
Ovarian Diseases
Recurrence
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Ovarian Neoplasms
Gonadal Disorders
Antineoplastic Agents
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Carboplatin

Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Therapeutic Uses
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009