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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00047801
Recruitment Status : Completed
First Posted : October 21, 2002
Last Update Posted : July 25, 2011
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Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Non-small-cell Lung Drug: TLK286 in combination with docetaxel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2002
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00047801

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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
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Responsible Party: Gail Brown, M.D. Chief Medical Officer, Telik, Inc. Identifier: NCT00047801    
Obsolete Identifiers: NCT00068705
Other Study ID Numbers: TLK286.2012
First Posted: October 21, 2002    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action