Ph II of Vinflunine and Cetuximab in Second Line Treatment of NSCLC
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: cetuximab; vinflunine
Intervention description: 400 mg/m² week 1,then 250 mg/m² weekly; Vinflunine 320 mg/m² every 21 days
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

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.
    

Eligibility 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:

          -  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

        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 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)