Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Sanofi
Study ID
NCT00356122
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    70 mg/m\^2 administered intravenously (IV) on Day 1 for Cycles 1-6 (the treatment cycle is 3 weeks)
  • Oxaliplatin — DRUG
    100 mg/m\^2 administered IV on Day 1 for Cycles 1-6
  • Bevacizumab — DRUG
    15 mg/kg administered IV on Day 1 for Cycles 1-6, and every 3 weeks during maintenance therapy for a total treatment of one year, until disease progression or death due to any cause, whichever occurs first.

Study Details

The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor and may also prevent tumor growth. The three investigational drugs are United States Food and Drug Administration (FDA) approved.

Key Dates

First listed
Jul 25, 2006
Start date
Jul 31, 2006
Status verified
Aug 2011
Primary completion
Aug 31, 2010
Completion
Aug 31, 2010

Study Design

Enrollment
53 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Docetaxel/Oxaliplatin/Bevacizumab
    Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of docetaxel, followed by oxaliplatin, and then bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Baseline to PFS (up to 24 months after the first treatment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sanofi-Aventis Administrative OfficeBridgewaterNew Jersey08807-

Find similar trials in Bridgewater, NJ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Sanofi-Aventis Administrative Office· Bridgewater, NJ

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