Status:
COMPLETED
Metronomic Vinorelbine and Bevacizumab in Patients With Non Small Cell Lung Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This trial will evaluate the efficacy and safety of metronomic vinorelbine and bevacizumab combination in patients with pretreated, advanced non small cell lung cancer
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00755170
Start Date
November 1 2008
End Date
October 1 2016
Last Update
October 4 2016
Active Locations (9)
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1
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
2
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
3
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
4
401 Military Hospital of Athens
Athens, Greece