A Phase II Trial of VInflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
Eligible patients will receive vinflunine as a 15-20 minute intravenous (IV)infusion once
every three weeks (21 days). This three week treatment period is called a cycle. Patients
whose cancer has not grown or if it has decreased in size may receive up to 6 cycles of
vinflunine. Evaluation will be conducted every other cycle.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.
David R. Spigel, MD
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI LUN 122
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