Carcinoma, Non-small-cell Lung
Conditions
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.
Interventions
DRUGTLK286 in combination with docetaxel
Sponsors
Telik
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Countries
United States
Outcome results
None listed