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

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer Read More

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)