First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC
NCT ID: NCT00456261
Last Updated: 2022-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2007-03-31
2012-09-30
Brief Summary
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Detailed Description
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The first group, Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
The second group, Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
In both regimens vitamin B12 injections and Folic Acid pills will be given to reduce the occurrence of side effects from the treatment.
Each patient's disease will be evaluated at intervals by the proper scans or X-rays to see how well the cancer is responding to the treatment.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort A
Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
Pemetrexed
pemetrexed 500 mg/m2
Gemcitabine
gemcitabine 1500 mg/m2
Bevacizumab
bevacizumab 10mg/kg bevacizumab 15mg/kg
Cohort B
Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
Pemetrexed
pemetrexed 500 mg/m2
Bevacizumab
bevacizumab 10mg/kg bevacizumab 15mg/kg
Carboplatin
carboplatin AUC=5
Interventions
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Pemetrexed
pemetrexed 500 mg/m2
Gemcitabine
gemcitabine 1500 mg/m2
Bevacizumab
bevacizumab 10mg/kg bevacizumab 15mg/kg
Carboplatin
carboplatin AUC=5
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have newly diagnosed unresectable stage III or stage IV disease are eligible.
* Must be at least 70 years of age
* Must have measurable disease by CT scan
* Must be able to be up and about and care for themselves
* May not have received prior treatment for stage III or IV disease
* Must have adequate white and red blood cells and platelets.
* Must be able to take Vitamin B12, Folic Acid and dexamethasone as stated in the study
* Must be able to understand the nature of this study and give written informed consent
* Adequate liver and kidney function
Exclusion Criteria
* Female patients who are pregnant or are lactating are ineligible
* History of unstable angina or myocardial infarction within 6 months prior to beginning bevacizumab
* Brain metastasis - cancer that has spread to the brain
* Major surgical procedure, open biopsy, or significant traumatic injury within 6 weeks of beginning bevacizumab or anticipation of need for major surgical procedure during the course of the study
* Full-dose oral or by vein anticoagulation or receiving anti-clotting therapy within 10 days of starting treatment
* Serious nonhealing wound, ulcer, or bone fracture
* Bleeding or clotting disorders
* Uncontrolled high blood pressure or serious heart arrhythmia requiring medication
* History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 6 months prior to beginning bevacizumab
* Chronic non-steroidal anti-inflammatory use is not allowed on study
* History of stroke or TIAs within the last 6 months
70 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
SCRI Development Innovations, LLC
OTHER
Responsible Party
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Principal Investigators
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David R Spigel, MD
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Locations
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Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
NEA Baptist Clinic
Jonesboro, Arkansas, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Wellstar Cancer Research
Marietta, Georgia, United States
Providence Medical Group
Terre Haute, Indiana, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Mercy Hospital
Portland, Maine, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Methodist Cancer Center
Omaha, Nebraska, United States
Cancer Care of Western North Carolina
Asheville, North Carolina, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Associates in Hematology Oncology
Chattanooga, Tennessee, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Countries
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References
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Spigel DR, Hainsworth JD, Shipley DL, Ervin TJ, Kohler PC, Lubiner ET, Peyton JD, Waterhouse DM, Burris HA 3rd, Greco FA. A randomized phase II trial of pemetrexed/gemcitabine/bevacizumab or pemetrexed/carboplatin/bevacizumab in the first-line treatment of elderly patients with advanced non-small cell lung cancer. J Thorac Oncol. 2012 Jan;7(1):196-202. doi: 10.1097/JTO.0b013e3182307efe.
Other Identifiers
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SCRI LUN 139
Identifier Type: -
Identifier Source: org_study_id
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