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

Sponsor
Telik (Industry)
Overall Status
Completed
CT.gov ID
NCT00047801
Collaborator
(none)
28
Enrollment
4
Locations
23
Duration (Months)
7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: TLK286 in combination with docetaxel
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
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 :
Oct 1, 2002
Actual Primary Completion Date :
Sep 1, 2004
Actual Study Completion Date :
Sep 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Institute Medical Group Los Angeles California United States 90025
    2 UCLA Medical Center Los Angeles California United States 90095
    3 Indiana University Cancer Center Indianapolis Indiana United States 46202
    4 M.D. Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Telik

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00047801
    Other Study ID Numbers:
    • TLK286.2012
    • NCT00068705
    First Posted:
    Oct 21, 2002
    Last Update Posted:
    Jul 25, 2011
    Last Verified:
    Jun 1, 2011
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Docetaxel

    Study Results

    No Results Posted as of Jul 25, 2011