A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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This is a Phase II, single-arm study in patients with stage IIIB (with malignant pleural effusion) and IV NSCLC who have been previously treated with a platinum-based doublet. Each cycle will be 21 days. On Day 1 of each cycle, patients will receive vinflunine 320 mg/m2 as a 20-minute IV infusion. Patients will continue to receive study treatment until disease progression or unacceptable toxicity. Patients will be evaluated every 2 cycles for response using RECIST criteria.

Official Title
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A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer

Conditions
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Non-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: To be eligible for the study, patients must fulfill all of the following criteria: Patients must have signed an IRB-approved informed consent. Patients must have recurrent or metastatic stage IIIB (with malignant pleural effusion) and IV NSCLC that has progressed after receiving a platinum-based doublet as first-line therapy. Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Previously irradiated lesions will not be allowed as measurable disease. Patients must have an ECOG Performance Status of 0, 1, or 2. Patients must be <18 years of age. Previous chemotherapy must have been completed at least 4 weeks prior to enrollment. Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months. Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter. Patients must have an absolute neutrophil count (ANC) >1500/uL, platelet count >100,000/uL, and hemoglobin >8 g/dL. Patients must have a serum creatinine <2 x institutional upper limit of normal (ULN). Patients must have a total bilirubin <2.5 x ULN and aspartate transaminase (AST) <5.0 x ULN. Exclusion Criteria: Any of the following criteria will make the patient ineligible to participate in this study: Patients previously treated with vinflunine or another vinca alkaloid. Patients with untreated and clinically unstable brain metastases. Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction. Patients with a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection. Patient has a co-existing malignancy or had a malignancy diagnosed within the last 3 years, with the exception of basal cell carcinoma or cervical cancer in situ. Patient received treatment with a non-approved or investigational drug within 30 days before planned start of study treatment. Patient is not completely healed from a previous oncologic or other major surgery. Patient is receiving or planning to receive any concurrent chemotherapy not indicated in the study protocol or an investigational agent during the study period. Patients who have a history of hypersensitivity to vinflunine or any of the components in vinflunine or another vinca alkaloid. Any patient who is pregnant or lactating. Any patient who is unable to comply with requirements of study.

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vinflunine|320 mg/m2 as a 20-minute IV infusion|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the 1-year survival rate in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. |  | unk | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess response rate (RR) of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet. |  | unk | 
| To assess overall survival in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. |  | unk | 
| To determine the progression-free survival (PFS) in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet |  | unk | 
| To assess time to response (TTR) in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. |  | unk | 
| To assess duration of overall response in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. |  | unk | 
| To assess duration of stable disease in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. |  | unk | 
| To assess the safety of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet. |  | unk |