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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014