Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00402883|
Recruitment Status : Terminated (Terminated due to bevacizumab and chemoradiotherapy toxicity)
First Posted : November 22, 2006
Results First Posted : January 13, 2014
Last Update Posted : January 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Bevacizumab Drug: Pemetrexed Procedure: Radiotherapy Other: Folic Acid Other: vitamin B12 Drug: carboplatin||Phase 2|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer|
|Study Start Date :||November 2006|
|Primary Completion Date :||January 2009|
|Study Completion Date :||January 2009|
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.
- Time to Progression [ Time Frame: 18 months ]
- To Evaluate the Objective Response Rates [ Time Frame: 18 months ]
- Overall Survival [ Time Frame: 18 months ]
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): 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|