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

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00620971
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    Vinorelbine (oral) 60 mg/m2, on days 1 and 8 every 3 weeks for 3 cycles
  • Cisplatin — DRUG
    Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 3 cycles
  • Bevacizumab — DRUG
    Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 3 cycles
  • Docetaxel — DRUG
    Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
  • Gemcitabine — DRUG
    Gemcitabine(IV) 1,100 mg/m2 on day 1 and d8 every 3 weeks for 6 cycles
  • Bevacizumab — DRUG
    Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles
  • Docetaxel — DRUG
    Docetaxel (IV) 75 mg/m2 on day 1 every 3 weeks for 6 cycles
  • Cisplatin — DRUG
    Cisplatin (IV) 80 mg/m2 on day 1 every 3 weeks for 6 cycles
  • Bevacizumab — DRUG
    Bevacizumab (IV) 15 mgr/Kgr on day 1 every 3 weeks for 6 cycles

Study Details

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.

Key Dates

Start date
Jan 31, 2008
Status verified
Jun 2014
Primary completion
Apr 30, 2010
Completion
Apr 30, 2010

Study Design

Enrollment
77 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    NC/Avastin-\>DG/Avastin
  • Experimental: 2
    DG/Avastin

Primary Outcome Measure

Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ]

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