Status:
COMPLETED
Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus the Cisplatin/Docetaxel/Bevacizumab Combination in Locally Advanced or Metastatic NSCLC
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This trial will evaluate whether the sequential administration of Cisplatin/Vinorelbine/Bevacizumab followed by Docetaxel/Gemcitabine/Bevacizumab versus the Cisplatin/Docetaxel/Bevacizumab combination...
Detailed Description
An unanswered question in first line treatment of non small cell lung cancer (NSCLC) is whether the administration of more than 2 active drugs provides greater efficacy than a two-drug combination. Do...
Eligibility Criteria
Inclusion
- Histologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) or metastatic (stage IV) non-squamous NSCLC
- Performance status (WHO) 0-1
- Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 2.5 UNL, ALP ≤ 5 UNL), and renal function (Creatinine ≤ UNL - if borderline, creatinine clearance should be ≥ 60 mL/min)
- No previous chemotherapy or immunotherapy for advanced/metastatic NSCLC is allowed
- -Previous radiotherapy is allowed provided that the measurable lesions are outside the radiation fields
- Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm
- Patient able to take oral medication
- Absence of active CNS disease
- Paraffin embedded sample of primary or metastatic tumor diagnostic specimen must be available
- Patients must be able to understand the nature of this study and give written informed consent
Exclusion
- Pregnant or lactating women
- Women of child-bearing age unable or unwilling to take effective contraceptive measures
- Active CNS disease, brain metastases, or leptomeningeal involvement
- Symptomatic neuropathy \> grade1 according to the NCI CTCAE (version 3.0)
- Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, LVEF \< normal, uncontrolled hypertension, ventricular arrhythmia), anticoagulation treatment or thrombotic event within the previous 6 months
- Active infection, requiring IV antibiotic treatment, within the previous 2 weeks
- Long-term oxygen therapy
- Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
- Radiotherapy within the previous 4 weeks
- Previous radiotherapy to the only measurable lesion
- Concurrent treatment with other anti-cancer drug
- Uncontrolled hypercalcemia
- Known allergy to drugs with similar chemical structure to study drugs. Concurrent corticosteroids, except for chronic therapy with methylprednisolone ≤ 20 mgr daily (or equivalent) for more than one month
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00620971
Start Date
January 1 2008
End Date
April 1 2010
Last Update
June 25 2014
Active Locations (9)
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1
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
2
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
3
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Athens, Greece
4
401 Military Hospital, Medical Oncology Unit
Athens, Greece