Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel in Platinum-Resistant Non-Small Cell Lung Cancer

This study has been completed.

First Received on October 18, 2002. Last Updated on July 21, 2011 History of Changes

Sponsor:	Telik
Information provided by:	Telik
ClinicalTrials.gov Identifier:	NCT00047801

Purpose

The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every three weeks in combination with docetaxel (Taxotere) in the treatment of patients with non-small cell lung cancer that is resistant to platinum-based chemotherapy.

Condition	Intervention	Phase
Carcinoma, Non-small-cell Lung	Drug: TLK286 in combination with docetaxel	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 Docetaxel (Taxotere) in Platinum-Resistant Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by Telik:

Estimated Enrollment:	28
Study Start Date:	October 2002
Study Completion Date:	September 2004
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion criteria include:

Histologically confirmed non-small cell bronchogenic carcinoma, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma with squamous cell carcinoma), bronchoalveolar carcinoma, or large cell carcinoma
Stage IV or Stage IIIB
Progressed during or after first-line therapies with platinum-containing regimens in the advanced or metastatic treatment regimen
At least 18 years of age
Good performance status (ECOG 0 to 1)
Adequate liver, renal, and bone marrow function

Exclusion criteria include:

Pregnant or lactating women
Treatment with more than one cytotoxic therapy
Prior radiation to the whole pelvis
Unstable medical conditions such as uncontrolled cardiac arrhythmia
Patients with known history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047801

Locations

United States, California
Cancer Institute Medical Group
Los Angeles, California, United States, 90025
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Telik

More Information

No publications provided

Responsible Party:	Gail Brown, M.D. Chief Medical Officer, Telik, Inc.
ClinicalTrials.gov Identifier:	NCT00047801 History of Changes
Obsolete Identifiers:	NCT00068705
Other Study ID Numbers:	TLK286.2012
Study First Received:	October 18, 2002
Last Updated:	July 21, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012