Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus the Cisplatin/Docetaxel/Bevacizumab Combination in Locally Advanced or Metastatic NSCLC

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will evaluate whether the sequential administration of Cisplatin/Vinorelbine/Bevacizumab followed by Docetaxel/Gemcitabine/Bevacizumab versus the Cisplatin/Docetaxel/Bevacizumab combination as first line treatment offers a survival advantage in patients with locally advanced or metastatic NSCLC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Bevacizumab; Cisplatin; Docetaxel; Gemcitabine; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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