Vinflunine and Cetuximab as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

This study has been terminated.
(Drug unavailable)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00519831
First received: August 21, 2007
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Lung Cancer
Biological: cetuximab
Drug: vinflunine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Overall tumor response rate as assessed by RECIST criteria [ Time Frame: Baseline, after cycle 2, within 2 weeks of completing cycle 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Time Frame: After cycle 4 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 30 days ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: after cycle 2, within 2 weeks of completing cycle 4 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: August 2007
Study Completion Date: November 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT 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)
  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: NCT00519831

Locations
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
Investigators
Principal Investigator: Thomas E. Stinchcombe, MD UNC Lineberger Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00519831     History of Changes
Obsolete Identifiers: NCT00330031
Other Study ID Numbers: UNC-LCCC-0503, CDR0000561613
Study First Received: August 21, 2007
Last Updated: February 1, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cetuximab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014