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	Treatment or Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: TLK286 in combination with docetaxel	Phase I Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Study ID Numbers:  TLK286.2012
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  October 18, 2002
ClinicalTrials.gov Identifier:  NCT00047801
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08