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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Veeda Oncology
ClinicalTrials.gov Identifier:
NCT00251446
First received: November 8, 2005
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Vinflunine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Veeda Oncology:

Primary Outcome Measures:
  • 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. [ Time Frame: unk ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: unk ] [ Designated as safety issue: No ]
  • To assess overall survival in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. [ Time Frame: unk ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: unk ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: unk ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: unk ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: unk ] [ Designated as safety issue: No ]
  • To assess the safety of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet. [ Time Frame: unk ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: October 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Vinflunine
    320 mg/m2 as a 20-minute IV infusion
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251446

Locations
United States, Texas
Veeda Oncology
Houston, Texas, United States, 77042
Sponsors and Collaborators
Veeda Oncology
Bristol-Myers Squibb
Investigators
Principal Investigator: Marcos Joppert, MD Veeda Oncology
  More Information

No publications provided

Responsible Party: Veeda Oncology
ClinicalTrials.gov Identifier: NCT00251446     History of Changes
Other Study ID Numbers: I-05-009
Study First Received: November 8, 2005
Last Updated: May 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014