Study of Oxaliplatin and Gemcitabine With or Without Bevacizumab to Treat Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Miami Beach, Florida.

Sponsor
Mt. Sinai Medical Center, Miami
Study ID
NCT00217282
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • oxaliplatin, gemcitabine, bevacizumab — DRUG
    Gemcitabine 1000mg/m2 IV over 30 minutes, on days 1 and 8 followed by Oxaliplatin 130mg/m2 IV over 2 hours on day 1 followed by Bevacizumab 15 mg/kg IV over 90\* minutes, on day 1 Cycles q 3 weeks x 4 cycles One cycle equals 3 weeks. Patients will be re-evaluated every 2 cycles. If CR, PR or SD, patients will continue treatment up to four cycles or until progression or unacceptable toxicity. Patients achieving CR, PR, or SD after 4 cycles will continue Bevacizumab maintenance: Bevacizumab 15 mg/kg IV q 3 weeks until relapse/progression

Study Details

The combination of oxaliplatin and gemcitabine has proven activity in advanced non-small cell lung cancer (NSCLC). Due to its favorable toxicity profile, this combination is optimal for adding new agents. Bevacizumab is an anti-VEGF monoclonal antibody that has also shown favorable results in advanced NSCLC. This study will add bevacizumab to oxaliplatin and gemcitabine as first line treatment in patients with Stage IIIB and IV NSCLC.

Key Dates

First listed
Sep 22, 2005
Start date
Jun 30, 2004
Status verified
May 2008
Primary completion
Jun 30, 2007
Completion
Mar 31, 2008

Study Design

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

Primary Outcome Measure

To determine the overall time to progression of the combination regimen of Gemcitabine, Oxaliplatin and Bevacizumab as first-line treatment in patients with Stage IIIB and IV non-small cell lung cancer. [ Time Frame: Prospective ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Medical CenterMiami BeachFlorida33140-

Find similar trials in Miami Beach, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Mount Sinai Medical Center· Miami Beach, FL

Related Studies