Clinical trial NCT00251446: A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer
Official title: A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Veeda Oncology
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-11-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: 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.
timeFrame: unk
Secondary outcomes:
measure: 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.
timeFrame: unk
measure: To assess overall survival in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.
timeFrame: unk
measure: 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
timeFrame: unk
measure: 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.
timeFrame: unk
measure: 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.
timeFrame: unk
measure: 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.
timeFrame: unk
measure: To assess the safety of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet.
timeFrame: unk
Other outcomes:
Locations:
city: Houston
country: United States
facility: Veeda Oncology
state: Texas
Study officials:
affiliation: Veeda Oncology
name: Marcos Joppert, MD
role: PRINCIPAL_INVESTIGATOR
References: