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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Vinflunine

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77042
      • Veeda Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Veeda Oncology
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Marcos Joppert, MD, Veeda Oncology

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: November 8, 2005
• First Submitted That Met QC Criteria: November 8, 2005
• First Posted (Estimate): November 10, 2005

Study Record Updates

• Last Update Posted (Estimate): May 11, 2012
• Last Update Submitted That Met QC Criteria: May 9, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: I-05-009