Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
The purpose of this study is to see if this combination of chemotherapy plus radiation therapy and immunotherapy (with bevacizumab) expands treatment options for patients with non-small cell lung cancer.
Other: Folic Acid
Other: vitamin B12
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer|
- Time to Progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- To Evaluate the Objective Response Rates [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.
Other Name: AvastinDrug: Pemetrexed
500mg/m2 week 1, 4, 16, 19 and 22.
Other Name: AlimtaProcedure: Radiotherapy
1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks)
Other Name: RTOther: Folic Acid
350 to 1,000 ug or equivalent supplementation administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinues study therapy.Other: vitamin B12
1,000ug administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinues therapy.Drug: carboplatin
AUC=5 administered intravenously weeks 1 and 4.
The patients on this study will receive treatment in 3 stages of therapy.
The first stage is Induction Therapy. This therapy is 7 weeks long. Patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 1 and 4. During Induction patients will also receive radiation therapy daily, Monday through Friday, for 7 weeks (weeks 1-7). This is followed by 2 weeks of rest. During this rest period patients will have scans done to see how their disease has responded to treatment.
The next stage of treatment is Consolidation Therapy. This stage is 10 weeks long. Patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 10, 13 and 16. This is followed by 3 weeks rest. During week 19 patients will have scans to see how their disease has responded to treatment.
The last stage of treatment is Maintenance Therapy. Patients will receive bevacizumab alone by vein every 3 weeks. Treatment will be given every three weeks for up to 9 treatments. (week 45)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402883
|United States, Florida|
|Gainsville Hematology Oncology Associates|
|Gainesville, Florida, United States, 32605|
|Watson Clinic Center for Cancer Care and Research|
|Lakeland, Florida, United States, 33805|
|United States, Georgia|
|Wellstar Cancer Research|
|Marietta, Georgia, United States, 30060|
|United States, Kentucky|
|Consultants in Blood Disorders and Cancer|
|Louisville, Kentucky, United States, 40207|
|United States, Ohio|
|Oncology Hematology Care|
|Cincinnati, Ohio, United States, 45242|
|United States, Tennessee|
|Associates in Hematology Oncology|
|Chattanooga, Tennessee, United States, 37404|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37023|
|Principal Investigator:||David Spigel, MD||SCRI Development Innovations, LLC|