Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT00323869
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody
  • Gemcitabine — DRUG
    Nucleoside analog
  • Carboplatin — DRUG
    Alkylating agent

Study Details

A multi-center study of bevacizumab in combination with gemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC).

Key Dates

First listed
May 10, 2006
Start date
Jun 30, 2006
Status verified
Jul 2016
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013

Study Design

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

Arms

  • Experimental: Bevacizumab + carboplatin + gemcitabine
    Bevacizumab in combination with carboplatin and gemcitabine: •Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles. Carboplatin was administered before the gemcitabine infusion: •Gemcitabine, administered 1000 mg/m² IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles Bevacizumab was administered 1 hour after end of all chemotherapy infusions: •Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: 18 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
VA Palo Alto Healthcare SystemPalo AltoCalifornia94304-1290-
Santa Clara Valley Medical CenterSan JoseCalifornia95128-
Stanford University School of MedicineStanfordCalifornia94305-

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