Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
NCT ID: NCT00402883
Last Updated: 2021-11-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2006-11-30
2009-01-31
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
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.
Bevacizumab
15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.
Pemetrexed
500mg/m2 week 1, 4, 16, 19 and 22.
Radiotherapy
1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks)
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.
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.
carboplatin
AUC=5 administered intravenously weeks 1 and 4.
Interventions
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Bevacizumab
15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.
Pemetrexed
500mg/m2 week 1, 4, 16, 19 and 22.
Radiotherapy
1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks)
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.
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.
carboplatin
AUC=5 administered intravenously weeks 1 and 4.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable or evaluable disease
* Be up and about and able to care for self
* Adequate kidney, liver and bone marrow function
* No prior treatment for this disease
* Must be able to give written informed consent
* Must be able to take folic acid, vitamin B12 and dexamethasone as described in the protocol
* Age 18 years or older
Exclusion Criteria
* Stage IIIB disease with contralateral mediastinal nodes greater than 4cm
* Squamous cell predominant tumors
* Pregnant or lactating women
* Patients with active infections
* History of another cancer within the last 5 years with the exception of skin cancer or cervical carcinoma in situ
* History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease
* Symptoms of peripheral vascular disease
* History of neurological disease
* Recent history of blood in the sputum or vomitus
* Non-healing wounds, ulcer or long bone fractures
* History of bleeding problems or coagulation problems
* History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 6 months
* History of uncontrolled hypertension
* Chronic use of non-steroidal anti-inflammatory medication not allowed on this study
18 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 Spigel, MD
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Locations
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Gainsville Hematology Oncology Associates
Gainesville, Florida, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States
Wellstar Cancer Research
Marietta, Georgia, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Associates in Hematology Oncology
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, Yardley DA, Raefsky E, Patton J, Peacock N, Farley C, Burris HA 3rd, Greco FA. Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol. 2010 Jan 1;28(1):43-8. doi: 10.1200/JCO.2009.24.7353. Epub 2009 Nov 9.
Related Links
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Published article in the Journal of Clinical Oncology
Other Identifiers
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SCRI LUN 134
Identifier Type: -
Identifier Source: org_study_id