Status:
COMPLETED
First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Genentech, Inc.
Eli Lilly and Company
Conditions:
Lung Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
This trial will look at 2 different drug combinations that have well known safety profiles and are known to be active against non small cell lung cancer and combine them with bevacizumab, an experimen...
Detailed Description
Patients in this study will be assigned to one of 2 treatment groups. The selection of the treatment groups will be done randomly by a computer. The first group, Cohort A, will receive bevacizumab 10...
Eligibility Criteria
Inclusion
- Histologically confirmed non-small cell bronchogenic carcinoma, (adenocarcinoma, or large cell carcinoma)
- 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
- Past or current history of cancer with the exception of treated non- melanoma skin cancer or carcinoma in-situ of the cervix, or other cancers cured by local therapy alone and have been disease free for five years
- 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
- Please Note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00456261
Start Date
March 1 2007
End Date
September 1 2012
Last Update
May 3 2022
Active Locations (18)
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1
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36207
2
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
3
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
4
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States, 33805