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

Stopped early · Phase 2

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00519831

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

18

Starts

2007-08-01

Expected to finish

2009-11-01

Last updated by the study team

2017-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Alamance Oncology/Hematology Associates, LLP — Burlington, North Carolina, United States
• Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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