- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00519831
Ph II of Vinflunine and Cetuximab in Second Line Treatment of NSCLC
Phase II Study of Vinflunine and Cetuximab in the Second Line Treatment of Stage IIIB/IV Non-Small Cell Lung Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
North Carolina
-
Burlington, North Carolina, United States, 27216
- Alamance Oncology/Hematology Associates, LLP
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
400 mg/m² week 1,then 250 mg/m² weekly
Other Names:
Vinflunine 320 mg/m² every 21 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Tumor Response Rate as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Sum of Partial Responses (PR) and Complete Responses (CR).
Time Frame: Baseline, after cycle 2, within 2 weeks of completing cycle 4
|
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10mm with spiral CT scan or nonmeasurable, but evaluable.
Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement.
|
Baseline, after cycle 2, within 2 weeks of completing cycle 4
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of Response
Time Frame: After cycle 4
|
After cycle 4
|
Overall Survival
Time Frame: Every 30 days
|
Every 30 days
|
Progression-free Survival
Time Frame: after cycle 2, within 2 weeks of completing cycle 4
|
after cycle 2, within 2 weeks of completing cycle 4
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNC LCCC 0503
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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