Evaluation of Non-cytotoxic Suramin as a Chemosensitizer in Non-small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT01038752|
Recruitment Status : Terminated
First Posted : December 24, 2009
Results First Posted : October 21, 2014
Last Update Posted : May 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Suramin Drug:Docetaxel Drug: Carboplatin Drug: Placebo Drug: Docetaxel Drug: Carboplatin||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||May 2013|
This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
Drug: Suramin Drug:Docetaxel Drug: Carboplatin
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 Comparator: Standard of care
This group will receive placebo with docetaxel and carboplatin.
Drug: Placebo Drug: Docetaxel Drug: Carboplatin
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).
- Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria [ 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. ]Insufficient data
- Overall Survival of Participants [ Time Frame: First treatment date to date of death ]Insufficient Data
- Overall Response Rate (Complete Response + Partial Response) of Participants [ Time Frame: Tumor assessment at every other cycle ]Insufficient data
- Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin. [ Time Frame: Day 1 of each cycle; end of treatment visit; at follow-up. ]Insufficient data.
- Pre-treatment bFGF Levels Correlation With Survival. [ Time Frame: Before first treatment ]Insufficient data.
- Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes [ Time Frame: Randomization date ]Insufficient data.
- To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients. [ Time Frame: Randomization date to date of death ]Insufficient data.
- 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. [ Time Frame: Randomization date to date of death ]Insufficient data.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038752
|United States, Illinois|
|John H Stroger Jr Hospital of Cook County|
|Chicago, Illinois, United States, 60612|
|United States, Virginia|
|Virginia Commonwealth University Massey Cancer Center|
|Richmond, Virginia, United States, 23298|