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

NCT ID: NCT00519831

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-11-30

Brief 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.

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

cetuximab

Intervention Type: BIOLOGICAL

400 mg/m² week 1,then 250 mg/m² weekly

vinflunine

Intervention Type: DRUG

Vinflunine 320 mg/m² every 21 days

Interventions

cetuximab

400 mg/m² week 1,then 250 mg/m² weekly

Intervention Type: BIOLOGICAL

vinflunine

Vinflunine 320 mg/m² every 21 days

Intervention Type: DRUG

Other Intervention Names

erbitux; Javlor

Eligibility Criteria

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

• 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

• 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:

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas E. Stinchcombe, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

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

Countries

United States

Other Identifiers

UNC LCCC 0503

Identifier Type: -

Identifier Source: org_study_id

NCT00330031

Identifier Type: -

Identifier Source: nct_alias