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.
Sponsor:
Information provided by:
Telik
ClinicalTrials.gov Identifier:
NCT00047801
First received: October 18, 2002
Last updated: July 21, 2011
Last verified: June 2011
  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 1
Phase 2

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:


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
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, see Learn About Clinical Studies.

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, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014