TLK286 (Telcyta) in Combination With Cisplatin for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.

First Received: February 12, 2004 Last Updated: January 10, 2008 History of Changes

Sponsor:	Telik
Information provided by:	Telik
ClinicalTrials.gov Identifier:	NCT00077883

Purpose

The purpose of this trial is to study the efficacy and safety of the combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: TLK286, cisplatin	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin

U.S. FDA Resources

Further study details as provided by Telik:

Estimated Enrollment:

Eligibility

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

Criteria

Inclusion Criteria:

18 years of age or older
Histologically confirmed non-small cell lung cancer
Stage IV or IIIB
Measurable disease by RECIST
ECOG performance status of 0-1
Adequate liver and renal function
Adequate bone marrow reserve

Exclusion Criteria:

History of bone marrow transplantation or stem cell support
Pregnant or lactating women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077883

Locations

United States, Maryland
Univ. of MD, Greenbaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Tennessee
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Texas
Univ. of TX, MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Telik

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	TLK286.2021
Study First Received:	February 12, 2004
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00077883 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Radiation-Sensitizing Agents
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 22, 2009