A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer
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
- 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
Any of the following criteria will make the patient ineligible to participate in this
- 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.