TerminatedPhase 2NCT00519831

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

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.

Checked against the public recordLast updated Jun 9, 2017 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations2
SponsorUNC Lineberger Comprehensive Cancer Center
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
UNC Lineberger Comprehensive Cancer Center
Interventions being studied
Biological: cetuximab; Drug: vinflunine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Alamance Oncology/Hematology Associates, LLPBurlington, North Carolina
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 9, 2017. Always confirm current availability with the study team.

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