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

Lung Cancer Clinical Trial

Official title:

Phase II Study of Vinflunine and Cetuximab in the Second Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00519831
• Other study ID #: UNC LCCC 0503
• Status: Terminated
• Phase: Phase 2
• First received: August 21, 2007
• Last updated: February 23, 2017
• Start date: August 2007
• Est. completion date: November 2009

Study information

• Verified date: February 2017
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00330031

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: November 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• cetuximab
400 mg/m² week 1,then 250 mg/m² weekly

Drug:
• vinflunine
Vinflunine 320 mg/m² every 21 days

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall tumor response rate as assessed by RECIST criteria		Baseline, after cycle 2, within 2 weeks of completing cycle 4
Secondary	Duration of response		After cycle 4
Secondary	Overall survival		Every 30 days
Secondary	Progression-free survival		after cycle 2, within 2 weeks of completing cycle 4