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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
14
Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour).
Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour).
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria
Insufficient data
Time frame: Patients will be followed every 2 months for the first 6 months following the last cycle of treatment, every three months for the next year, and every 6 months thereafter.
Overall Survival of Participants
Insufficient Data
Time frame: First treatment date to date of death
Overall Response Rate (Complete Response + Partial Response) of Participants
Insufficient data
Time frame: Tumor assessment at every other cycle
Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin.
Insufficient data.
Time frame: Day 1 of each cycle; end of treatment visit; at follow-up.
Pre-treatment bFGF Levels Correlation With Survival.
Insufficient data.
Time frame: Before first treatment
Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes
Insufficient data.
Time frame: Randomization date
To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients.
Insufficient data.
Time frame: Randomization date to date of death
To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Greater Survival Benefits in African-American Patients Compared to Non-African-American Patients.
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Insufficient data.
Time frame: Randomization date to date of death