A Study of Cisplatin + Pemetrexed + Avastin as First-Line Therapy

Part of paid clinical trials in Lake Success, New York.

Sponsor
Columbia University
Study ID
NCT00998166
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Pemetrexed — DRUG
    1. Pre-hydration for 1-1/2 hours at 250 ml/hour 2. Pemetrexed 500 mg/m2 IV over 10 minutes 3. Return to hydration for 30 minutes at 250 ml/hour
  • Cisplatin — DRUG
    4\. Cisplatin 75mg/m2 IV over 60-120 minutes
  • Bevacizumab — DRUG
    5\. Bevacizumab 15mg/kg IV over 90 minutes

Study Details

In the past, patients with advanced lung cancer who were inoperable underwent chemotherapy with one or more chemotherapeutic agents. More recently, novel new agents targeting specific enzymes or pathways responsible for cell division have been developed and clinicians have begun to utilize various combinations of these drugs with standard chemotherapeutic agents for the treatment of NSCLC. Some of these approaches have demonstrated a small but significant increase in survival among patients with advanced disease. Because a recently completed Phase 3 study of bevacizumab + Taxol/Carboplatin in first line NSCLC therapy demonstrated a 23% improvement in median survival, it would be appealing to see if a regimen of bevacizumab/ cisplatin/Alimta would also demonstrate a similar, or perhaps better, response rate.

Key Dates

First listed
Oct 20, 2009
Start date
Jun 30, 2009
Status verified
Jul 2024
Primary completion
Oct 31, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pemetrexed, Cisplatin, Bevacizumab
    Chemotherapy infusion on Day 1 of a 3-week cycle

Primary Outcome Measure

Prevalence of Progression Free Survival (PFS) [ Time Frame: Up to 1 year ]

Locations (2)

FacilityCityStateZIPSite coordinators
North Shore University HospitalLake SuccessNew York11042-
Columbia University Medical CenterNew YorkNew York10032-

Find similar trials in Lake Success, NY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
North Shore University Hospital· Lake Success, NYColumbia University Medical Center· New York, NY

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