Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer

Study Overview
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Brief Summary
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This clinical trial involves the administration of the chemotherapeutic medication vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of extensive small cell lung cancer. The purpose of this research trial is to study the effectiveness of vinflunine in patients with relapsed extensive small cell lung cancer, evaluate the toxicity, and evaluate how long the response to this drug lasts.

Detailed Description
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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.

Official Title
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A Phase II Trial of VInflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer

Conditions
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Carcinoma, Small Cell, Lung Cancer

Intervention / Treatment
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* Drug: Vinflunine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen Measurable or evaluable disease Able to perform activities of daily living with minimal assistance Adequate hematological, liver, and kidney function Must give written informed consent prior to entry Exclusion Criteria: CNS involvement Serious active infection or underlying medical condition Significant history of uncontrolled cardiac disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. | Drug: Vinflunine<br>* 320mg/m2 every 21 days as a 15-20 minute infusion<br>* Other names: Javlor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease | The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease. | 18 months | 
| Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | Overall survival was measured from the date of study entry until the date of death. | 18 months | 
| 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 | Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extensive stage, Relapsed