Vinflunine and Cetuximab as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00519831
• Date of registration: 21/08/2007
• Primary sponsor: UNC Lineberger Comprehensive Cancer Center
• Public title: Vinflunine and Cetuximab as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
• Scientific title: Phase II Study of Vinflunine and Cetuximab in the Second Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer
• Date of first enrolment: August 2007
• Target sample size: 16
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00519831
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Thomas E. Stinchcombe, MD
• Affiliation: UNC Lineberger Comprehensive Cancer Center

Key inclusion & exclusion 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:

- ECOG performance status 0-2

- ANC > 1,000/mm³

- Hemoglobin > 8.0 g/dL

- Platelet count > 75,000/mm³

- Creatinine < 2.0 times upper limit of normal (ULN)

- AST and 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 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Cancer

Intervention(s)

Biological: cetuximab

Drug: vinflunine

Primary Outcome(s)

Overall tumor response rate as assessed by RECIST criteria [Time Frame: Baseline, after cycle 2, within 2 weeks of completing cycle 4]

Secondary Outcome(s)

Duration of response [Time Frame: After cycle 4]

Overall survival [Time Frame: Every 30 days]

Progression-free survival [Time Frame: after cycle 2, within 2 weeks of completing cycle 4]

Secondary ID(s)

CDR0000561613

UNC-LCCC-0503

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)