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

NCT00251446 | Completed Phase 2

• 1 other identifier: I-05-009
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

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Secondary Outcomes (7)

• 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.

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• To assess overall survival in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet.

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• 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

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• 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.

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• 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.

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Interventions

Vinflunine DRUG

320 mg/m2 as a 20-minute IV infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Veeda Oncology: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Veeda Oncology

Houston, Texas, 77042, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

vinflunine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marcos Joppert, MD

  Veeda Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2005
• First Posted: November 10, 2005
• Study Start: October 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: May 11, 2012

Record last verified: 2012-05

Locations

US (1)