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

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Marcos Joppert, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Veeda Oncology


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

March 2008

Related Keywords:

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



Veeda Oncology Houston, Texas  77042