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

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

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.

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.