A Phase II Study of the Combination of Metronomic Vinorelbine and Bevacizumab as 2nd Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)
18 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
A Phase II Study of the Combination of Metronomic Vinorelbine and Bevacizumab as 2nd Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)
Intravenous (IV) vinorelbine is a standard chemotherapy option for the treatment of
metastatic NSCLC, either alone or in combination with other agents such as CDDP or
Carboplatin with overall response rates (ORR) of 15-35% as 1st line treatment and less than
10% as salvage treatment. For the past few years vinorelbine is available for per os (po)
administration with acceptable and reliable pharmacokinetic profiles and with a
bioavailability of approximately 40% of the IV dose. In randomized phase II studies IV and
po vinorelbine have shown comparable response and overall survival rates. The low dose
metronomic chemotherapy that is administered in short intervals has been shown in vitro an
in vivo to have antiangiogenic effects. Bevacizumab is a well known anti-angiogenic agent.
Recently, a phase III study of 1st line treatment in patients with advanced or metastatic
NSCLC showed that the addition of bevacizumab to a platinum-based regimen provided a
survival benefit. This study will evaluate the combination of metronomic vinorelbine and
bevavizumab as 2nd line treatment of NSCLC.
Inclusion Criteria:
- Histologically or cytologically confirmed, metastatic (stage IV) non small cell lung
cancer
- One previous platinum based chemotherapy regimen with or without taxanes for
metastatic NSCLC
- Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10
mm
- Age ≥ 18 years
- Performance status (WHO) 0-2
- Life expectancy of at least 12 weeks
- Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver
(Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 2.5 upper normal limit in the
absence of liver metastases or ≤ 5 upper normal limit in the presence of liver
metastases), and renal function (Creatinine ≤ 1,5 upper normal limit)
- Patients must be able to understand the nature of this study
- Written informed consent
Exclusion Criteria:
- Second primary malignancy, except for non-melanoma skin cancer. Pregnant or lactating
women
- Any serious, uncontrolled comorbidity on the investigator's judgment
- Uncontrolled infection
- Any sustained chronic toxicity > grade 2 according to the NCI CTCAE (version 3.0)
- Brain metastases, except if radiated and asymptomatic
- Radiotherapy within the previous 4 weeks
- Previous radiotherapy to the only measurable lesion
- Proteinuria ≥ 500 mgr of protein daily
- Hemoptysis > 10 cc per event
- Clinically significant hematemesis
- Centrally located lesion or in contact with major vessels
- Pulmonary lesion with cavitation
- Documented hemorrhagic diathesis or coagulation disorder
- Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial
infarction within the previous 4 months, unstable angina, LVEF < normal, ventricular
arrhythmia, uncontrolled hypertension)
- Thrombotic event within the previous 6 months
- Concurrent use of aspirin > 325 mgr daily, low molecular weight heparin in
therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents
- Concurrent treatment with other anti-cancer drug
- Major surgical procedure within the previous 4 weeks
- Serum Να+ < 120mg/dL
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Safety Issue:
No
Principal Investigator
Sofia Agelaki, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital of Crete, Dep of Medical Oncology
Authority:
Greece: National Organization of Medicines
Study ID:
CT/08.18
NCT ID:
NCT00755170
Start Date:
November 2008
Completion Date:
March 2013
Related Keywords:
- Non Small Cell Lung Cancer
- Vinorelbine
- Bevacizumab
- Chemotherapy
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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