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
- Bevacizumab, Oxaliplatin, Pemetrexed — DRUGAvastin 15 mg/kg IV, Alimta 500 mg/m2 IV given over 10 minutes, Eloxatin 120 mg/m2 IV given over 2 hours
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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Veeda Oncology | Columbus | Ohio | 43215 | - |
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