A Phase II Study of Eloxatin and Alimta in Combination With Bevacizumab in Advanced Non-Squamous NSCLC

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Veeda Oncology
Study ID
NCT00251524
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a Phase II, open-label, non-randomized study in patients with advanced non-squamous NSCLC. Each cycle will be 21 days. Patients will be evaluated every 2 cycles (\~6 weeks) for response using RECIST criteria. Those patients achieving stable disease or better will continue therapy. Those patients experiencing progressive disease will be taken off study. Patients will receive 6 cycles of Eloxatin, Alimta, and Bevacizumab. After the 6 cycles, patients will receive Bevacizumab alone every 21 days until evidence of disease progression or unacceptable toxicity. Note: Once patient has completed the 6 cycles of Eloxatin, Alimta, and Bevacizumab and is receiving single-agent Bevacizumab, assessment of response will be performed every 3 cycles (\~every 9 weeks) using RECIST criteria.

Key Dates

First listed
Nov 10, 2005
Start date
Nov 30, 2005
Status verified
May 2012
Primary completion
May 31, 2009
Completion
May 31, 2009

Study Design

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

Primary Outcome Measure

To determine the median progression-free survival in patients with advanced non-squamous non-small cell lung cancer (NSCLC) receiving Eloxatin and Alimta in combination with Bevacizumab as first-line treatment [ Time Frame: unk ]

Locations (1)

FacilityCityStateZIPSite coordinators
Veeda OncologyColumbusOhio43215-

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