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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251446
• Other study ID #: I-05-009
• Status: Completed
• Phase: Phase 2
• First received: November 8, 2005
• Last updated: May 9, 2012
• Start date: October 2005
• Est. completion date: March 2008

Study information

• Verified date: May 2012
• Source: Veeda Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Vinflunine
320 mg/m2 as a 20-minute IV infusion

Locations

Country	Name	City	State
United States	Veeda Oncology	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Veeda Oncology	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes