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Phase II Study of Vinflunine and Cetuximab in the Second Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Study of Vinflunine and Cetuximab in the Second Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer



- Estimate the objective response rate in patients receiving vinflunine and cetuximab as
second-line therapy for stage IIIB or IV non-small cell lung cancer.


- Determine the progression-free survival of patients treated with this regimen.

- Determine the safety of this regimen in these patients.

- Determine the overall survival of patients treated with this regimen.

- Determine the duration of overall response in these patients.

OUTLINE: This is a multicenter study.

Patients receive vinflunine IV over 15-20 minutes on day 1 and cetuximab IV over 60-120
minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence
of disease progression or unacceptable toxicity. Patients with responding disease may
receive additional courses beyond 4 courses at the discretion of the principal investigator.

After completion of study therapy, patients are followed periodically for 6 months.

Inclusion Criteria


- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting
1 of the following criteria:

- Unresectable stage IIIB disease with pleural effusion or pericardial effusion

- Stage IIIB disease that was treated with chemotherapy alone as first-line

- Stage IV disease

- Must have documented progression of disease after receiving one cytotoxic
chemotherapy regimen for metastatic disease

- At least one lesion that is bidimensionally measurable by CT scan or MRI

- Must have evaluable disease outside the radiation field

- New lesions that develop within the radiation field are allowed

- Measurable disease status as defined by RECIST criteria

- Brain metastases allowed provided they have been previously treated and are


Inclusion criteria:

- ECOG performance status 0-2

- ANC > 1,000/mm³

- Hemoglobin > 8.0 g/dL

- Platelet count > 75,000/mm³

- Creatinine < 2.0 times upper limit of normal (ULN)

- AST and ALT < 5 times ULN

- Total bilirubin < 2.5 times ULN

- Prior malignancy allowed provided the patient's life expectancy is best defined by
the diagnosis of NSCLC

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for up to 4 weeks after
completion of study therapy

Exclusion criteria:

- Peripheral neuropathy ≥ 2

- Severe allergic reaction to prior vinca alkaloid treatment

- Active or uncontrolled infection

- Significant history of uncontrolled cardiac disease, including any of the following:

- Uncontrolled hypertension

- Unstable angina

- Myocardial infarction within the past 6 months

- Uncontrolled congestive heart failure

- Cardiomyopathy with decreased ejection fraction

- Severe reaction to prior monoclonal antibody therapy


Inclusion criteria:

- See Disease Characteristics

- Prior oral tyrosine kinase inhibitor therapy (e.g. gefitinib or erlotinib) allowed

- Not considered cytotoxic therapy for study eligibility purposes if given alone
as first-line therapy

- At least 1 week since prior radiotherapy

- At least 21 days since prior and no other concurrent chemotherapy

- Prior adjuvant therapy allowed provided patient received one cytotoxic chemotherapy
regimen as treatment for metastatic disease

- Prior bevacizumab allowed

Exclusion criteria:

- Two or more cytotoxic chemotherapy regimens as treatment for metastatic disease

- Prior therapy with monoclonal antibody directed at the EGFR pathway

- Prior therapy with a vinca alkaloid in the metastatic setting

- Concurrent bevacizumab

- Other concurrent investigational agent(s)

- Concurrent colony-stimulating factors as primary prophylaxis for the prevention of
febrile neutropenia

- Concurrent CYP3A4 inhibitor(s)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall tumor response rate as assessed by RECIST criteria

Outcome Time Frame:

Baseline, after cycle 2, within 2 weeks of completing cycle 4

Safety Issue:


Principal Investigator

Thomas E. Stinchcombe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

November 2009

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Alamance Oncology/Hematology Associates, LLP Burlington, North Carolina  27216