Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00284154|
Recruitment Status : Completed
First Posted : January 31, 2006
Results First Posted : March 13, 2013
Last Update Posted : March 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Small Cell Lung Cancer||Drug: Vinflunine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of VInflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||November 2009|
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
320mg/m2 every 21 days as a 15-20 minute infusion
Other Name: Javlor
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ]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.
- Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease [ Time Frame: 18 months ]The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
- Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [ Time Frame: 18 months ]Overall survival was measured from the date of study entry until the date of death.
- Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease [ Time Frame: 18 months ]Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284154
|United States, Florida|
|Florida Cancer Specialists|
|Fort Myers, Florida, United States, 33901|
|United States, Ohio|
|Oncology Hematology Care|
|Cincinnati, Ohio, United States, 45242|
|United States, Tennessee|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37023|
|Principal Investigator:||David R. Spigel, MD||SCRI Development Innovations, LLC|