TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer - Full Text View

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

This study has been completed.

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

ChemIDplus related topics:

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

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

Study placed in the following topic categories:

Genital Diseases, Female

Ovarian cancer

Ovarian Neoplasms

Gonadal Disorders

Genital Neoplasms, Female

Endocrine System Diseases

Urogenital Neoplasms

Carboplatin

Endocrinopathy

Ovarian Diseases

Recurrence

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

Adnexal Diseases

ClinicalTrials.gov processed this record on September 05, 2008