Ph II of Vinflunine and Cetuximab in Second Line Treatment of NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00519831
Recruitment Status : Terminated (Drug unavailable)
First Posted : August 23, 2007
Results First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Bristol-Myers Squibb
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as vinflunine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Giving vinflunine together with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving vinflunine together with cetuximab works as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: cetuximab Drug: vinflunine Phase 2

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Vinflunine and Cetuximab in the Second Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer
Study Start Date : August 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Cetuximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vinflunine + Cetuximab
Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.
Biological: cetuximab
400 mg/m² week 1,then 250 mg/m² weekly
Other Name: erbitux
Drug: vinflunine
Vinflunine 320 mg/m² every 21 days
Other Name: Javlor

Primary Outcome Measures :
  1. Overall Tumor Response Rate as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Sum of Partial Responses (PR) and Complete Responses (CR). [ Time Frame: Baseline, after cycle 2, within 2 weeks of completing cycle 4 ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement.

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: After cycle 4 ]
  2. Overall Survival [ Time Frame: Every 30 days ]
  3. Progression-free Survival [ Time Frame: after cycle 2, within 2 weeks of completing cycle 4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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 therapy
    • 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 controlled


Inclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) > 1,000/mm³
  • Hemoglobin > 8.0 g/dL
  • Platelet count > 75,000/mm³
  • Creatinine < 2.0 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (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 epidermal growth factor receptor (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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00519831

United States, North Carolina
Alamance Oncology/Hematology Associates, LLP
Burlington, North Carolina, United States, 27216
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Bristol-Myers Squibb
Principal Investigator: Thomas E. Stinchcombe, MD UNC Lineberger Comprehensive Cancer Center

Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT00519831     History of Changes
Obsolete Identifiers: NCT00330031
Other Study ID Numbers: UNC LCCC 0503
First Posted: August 23, 2007    Key Record Dates
Results First Posted: June 9, 2017
Last Update Posted: June 9, 2017
Last Verified: May 2017

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action