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

NCT00620971 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2014-06-25

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Gemcitabine

Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles

DRUG

Bevacizumab

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles

DRUG

Docetaxel

Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles

DRUG

Cisplatin

Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles

DRUG

Bevacizumab

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles

DRUG

Vinorelbine

Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles

DRUG

Cisplatin

Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles

DRUG

Bevacizumab

Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles

DRUG

Docetaxel

Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles

Sponsors & Collaborators

  • University Hospital of Crete

    collaborator OTHER

  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

  • Vassilis Georgoulias, MD · University Hospital of Crete, Dep of Medical Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00620971 on ClinicalTrials.gov