a phase ii single arm trial of single-agent vinflunine as second-line treatment of advanced non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: 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.


Eligibility 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.