Carboplatin, Bevacizumab and Pemetrexed in Advanced Non Small Cell Lung Cancer (H3E-US-X072)
|Non Small Cell Lung Cancer||Drug: Carboplatin, Pemetrexed and Bevacizumab||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Carboplatin, Bevacizumab and Pemetrexed in Advanced Non-Small Cell Lung Cancer|
- efficacy of a novel combination of Carboplatin, Pemetrexed and Bevacizumab used concurrently in the treatment of NSCLC [ Time Frame: CT scans to determine evaluation of response after 2 cycles of treatment ]
- assessment of treatment tolerability measured by adverse events such as grade 4 toxicities, hospitalizations for toxicities, fever and neutropenia events and clinically significant bleeding/thrombotic events [ Time Frame: will document all adverse experiences after the start of the study and will follow up subjects until event has disappeared or condition stabilized ]
|Study Start Date:||November 2007|
|Study Completion Date:||August 22, 2016|
|Primary Completion Date:||August 22, 2016 (Final data collection date for primary outcome measure)|
one arm for study
Carboplatin, Pemetrexed and Bevacizumab are given day 1 every 3 weeks for 6 cycles and will be continued if patient tolerates treatments and has stable disease. The Bevacizumab will be continued every 3 weeks for 1 year if the patient tolerates treatment and has stable disease.
Drug: Carboplatin, Pemetrexed and Bevacizumab
Carboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles
Carboplatin: AUC 5 IV over 30-60 minutes on day 1 Pemetrexed: 500mg/M2 IV over 10 minutes on day 1 Bevacizumab: 15mg/kg IV over 90 minutes on day 1 (if rate is tolerated the 2nd dose may be decreased to 60 minutes and subsequent doses to 30 minutes This regimen will be administered every 6 weeks for up to a maximum of 6 cycles if the patient tolerates the treatment and has stable disease. Bevacizumab will be continues if tolerated for up to 1 year at every 3 week intervals.
Folic acid 1mg by mouth daily, Vitamin B12 1000 ug IM every 9 weeks and Dexamethasone 4mg by mouth twice a day and and antiemetic may be prescribed by the physician investigator to help reduce side effects associated with the Pemetrexed. The Folic acid and Vitamin B12 will continue until 3 weeks after the end of treatment.
Physical exams, vital signs and blood work will be done prior to each chemotherapy cycle. A urine dipstick to check for protein in the urine will be done prior to the first treatment and before cycles 3 and 5. A CAT scan of the chest will be done pretreatment, prior to cycles 3 and 5 and at the end of treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614822
|Principal Investigator:||Michael Guarino, MD||Christiana Care Health Services|