Non-small Cell Lung Cancer Clinical Trial
Official title:
Combination of Non-Cytotoxic Suramin With Docetaxel and Carboplatin in Chemo-Naive Non-small Cell Lung Cancer (NSCLC): A Randomized Single-Blind Placebo-Controlled Phase II Study
The purpose of this study is to evaluate the benefit of adding suramin at a non-cytotoxic dose to carboplatin and docetaxel regimen in the treatment of chemo-naïve patients with non-small cell lung cancer.
The primary objective is to determine the progression free survival for patients with stage
III B with malignant pleural effusion or Stage IV NSCLC treated with docetaxel and
carboplatin with or without suramin.
The secondary objectives are to compare median overall survival rate, compare overall
response rate of patients in both arms, assess toxicity of suramin with docetaxel and
carboplatin, determine whether pre-treatment bFGF levels correlate with survival, to
determine whether survival benefit from suramin is associated with M phase entry in
peripheral blood lymphocytes, and to determine whether adding suramin to docetaxel and
carboplatin produces greater survival benefits in African-American patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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