Status:
COMPLETED
Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lung Cancer, Non-Small Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The current prognosis for patients with metastatic brain cancer from NSCLC is very poor. The current standard treatment for this disease is radiation therapy to the brain. The goal of the current stud...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC)
- Must have received previous chemotherapy
- Must be 18 years of age of greater
- Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2
- At least 2 weeks must have elapsed since any surgery
- At least 4 weeks must have elapsed since any radiation to a non-CNS site
- Must have adequate bone marrow, renal, and live capacities
- Women must be of non-childbearing potential or practice adequate birth control
- Males must practice adequate methods of birth control
- Must sign written informed consent
- Exclusion criteria:
- Previous whole brain radiation therapy
- Prior treatment with topotecan
- Investigational agent within 30 days or 5 half-live
- Concomitant therapy with inhibitors of breast cancer resistance protein (BCRP) or P-glycoprotein such as erlotinib or gefitinib
- Primary or secondary immunodeficiencies
- Gastrointestinal conditions that affect GI absorption or motility
- Uncontrolled emesis
- Brain metastasis at time of initial diagnosis of NSCLC
- History of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin cancer, low grade prostate cancer
- Pregnant or intending to become pregnant or intending to father a baby
- Any severe concurrent medical condition that could affect compliance.
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT00390806
Start Date
December 1 2006
End Date
September 1 2013
Last Update
January 20 2014
Active Locations (88)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35294
2
GSK Investigational Site
Glendale, Arizona, United States, 85304
3
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
4
GSK Investigational Site
Anaheim, California, United States, 92801