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

Information source: Hellenic Oncology Research Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Small Cell Lung Cancer

Intervention: Vinorelbine (Drug); Cisplatin (Drug); Bevacizumab (Drug); Docetaxel (Drug); Gemcitabine (Drug); Bevacizumab (Drug); Docetaxel (Drug); Cisplatin (Drug); Bevacizumab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hellenic Oncology Research Group

Official(s) and/or principal investigator(s):
Vassilis Georgoulias, MD, Principal Investigator, Affiliation: University Hospital of Crete, Dep of Medical Oncology


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.

Clinical Details

Official title: Sequential Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus Cisplatin/Docetaxel/Bevacizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Response Rate

Secondary outcome:

Time to Tumor Progression

Overall Survival

Quality of life assessment

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. Docetaxel/gemcitabine combination is a well tolerated regimen, which has comparable efficacy to docetaxel/cisplatin or vinorelbine/cisplatin. In a recent phase II study in first line treatment of advanced or metastatic NSCLC, the sequential administration of vinorelbine/cisplatin followed by docetaxel/gemcitabine produced a response rate of 45. 8% and a 1-year survival rate of 51%. The addition of bevacizumab to a platinum-based regimen provided a survival benefit in patients with advanced or metastatic NSCLC.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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


- Patient able to take oral medication

- Absence of active CNS disease

- Paraffin embedded sample of primary or metastatic tumor diagnostic specimen must be


- 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


- 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


- 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

Locations and Contacts

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece

"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology, Athens, Greece

401 Military Hospital, Medical Oncology Unit, Athens, Greece

Air Forces Military Hospital, Dep of Medical Oncology, Athens, Greece

IASO" General Hospital of Athens, 1st Dep of Medical Oncology, Athens, Greece

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases, Athens, Greece

Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases, Athens, Greece

"Theagenion" Anticancer Hospital of Thessaloniki, Thessaloniki, Greece

Additional Information

Starting date: January 2008
Last updated: June 24, 2014

Page last updated: August 23, 2015

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