A Phase II Study of Eloxatin and Alimta in Combination With Bevacizumab in Advanced Non-Squamous NSCLC
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|ClinicalTrials.gov Identifier: NCT00251524|
Recruitment Status : Completed
First Posted : November 10, 2005
Last Update Posted : May 11, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: Bevacizumab, Oxaliplatin, Pemetrexed||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Eloxatin and Alimta in Combination With Bevacizumab in Advanced Non-Squamous NSCLC|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
- Drug: Bevacizumab, Oxaliplatin, Pemetrexed
Avastin 15 mg/kg IV, Alimta 500 mg/m2 IV given over 10 minutes, Eloxatin 120 mg/m2 IV given over 2 hoursOther Name: Avastin
- 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 ]
- To evaluate the median and the 1-year and 2-year survival in patients with advanced NSCLC receiving Eloxatin and Alimta in combination with Bevacizumab as first-line treatment. [ Time Frame: unk ]
- To determine the overall objective response and the duration of response in patients with advanced NSCLC receiving Eloxatin and Alimta in combination with Bevacizumab as first-line treatment. [ Time Frame: unk ]
- To evaluate the safety of Eloxatin and Alimta in combination with Bevacizumab in patients with advanced NSCLC as first-line treatment. [ Time Frame: unk ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251524
|United States, Ohio|
|Columbus, Ohio, United States, 43215|
|Principal Investigator:||John Waples, MD||Veeda Oncology|