Last updated: 11/04/2018 08:15:58
Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Phase III, Open-Label Study of Oral Topotecan Plus Whole-Brain Radiation Therapy (WBRT) Compared with WBRT Alone in Patients with Brain Metastases from Non-Small Cell Lung Cancer
Trial description: 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 study is to test whether the combination of orally administered HYCAMTIN capsules and whole brain radiation therapy will prolong the survival time of patients with this potentially serious condition.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Overall Survival
Timeframe: From the time of Randomization until the date of death due to any cause (up to 195 weeks)
Secondary outcomes:
Six-month survival
Timeframe: Month 6
Number of participants with a complete response (CR) or a partial response (PR) (central nervous system [CNS]-radiologic)
Timeframe: From the time of Randomization until the time of CR or PR (up to 75 weeks)
Time to response (TTR) (CNS-radiologic)
Timeframe: From the time of Randomization until the first documented evidence of CR or PR (up to 75 weeks)
Time to progression (TTP) (CNS-radiologic)
Timeframe: From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)
Time to progression (TTP) (all sites of disease-radiologic)
Timeframe: From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)
Number of participants who ranked each individual indicated neurological sign and symptom as none, mild, moderate, or severe at Months 1 and 3
Timeframe: Months 1 and 3
Number of participants with the indicated investigator assessment for the neurological sign and symptom of level of consciousness at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment for the neurological sign and symptom of headache at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment for the neurological sign and symptom of dizziness/lightheadedness at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment for the neurological sign and symptom of vertigo at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment for the neurological sign and symptom of nausea/vomiting at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment for the neurological sign and symptom of visual problem at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment for the neurological sign and symptom of seizure at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment for the neurological sign and symptom of other neurological symptoms at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment of cranial nerves II-XII at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment of language (dysphasia or aphasia) at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment of strength (right upper extremity) at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment of strength (left upper extremity) at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment of strength (right lower extremity) at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment of strength (left lower extremity) at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment of sensation at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment of ataxia (right upper extremity: finger to nose testing) at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment of ataxia (left upper extremity: finger to nose testing) at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment of ataxia (gait) at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with the indicated investigator assessment of ataxia (balance) at Baseline, Month 1, and Month 3
Timeframe: Baseline, Month 1, and Month 3
Number of participants with any adverse event (AE; both serious and non-serious) or serious adverse event (SAE)
Timeframe: From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)
Number of participants with the indicated worst-case change from Baseline in the indicated chemistry parameters with respect to the normal range
Timeframe: From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)
Lesion assessment and measurement
Timeframe: From the time of Randomization until the time of CR or PR (up to 75 weeks)
Brain symptoms
Timeframe: Baseline, Month 1, and Month 3
Number of participants who died or progressed
Timeframe: From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)
Interventions:
Drug: HYCAMTIN, oral capsules
Radiation: Radiation
Enrollment:
472
Observational study model:
Not applicable
Primary completion date:
2012-12-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lung Cancer, Non-Small Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
December 2006 to July 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC)
- Must have received previous chemotherapy
- Previous whole brain radiation therapy
- Prior treatment with topotecan
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Tampa, Florida, United States, 33612
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Albany, New York, United States, 12206
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89135
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vancouver, Washington, United States, 98684
Status
Study Complete
Location
GSK Investigational Site
Eugene, Oregon, United States, 97401-8122
Status
Study Complete
Location
GSK Investigational Site
Rockford, Illinois, United States, 61108
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46227
Status
Study Complete
Location
GSK Investigational Site
Sherman, Texas, United States, 75090
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39216
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbus, Ohio, United States, 43235
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Elk Grove Village, Illinois, United States, 60007
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Buffalo, New York, United States, 14215
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbia, Missouri, United States, 65201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55455
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Skokie, Illinois, United States, 60077
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87109
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Buffalo, New York, United States, 14215-1199
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Duncanville, Texas, United States, 75137
Status
Study Complete
Location
GSK Investigational Site
Tampa, Florida, United States, 33606
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pleasant Hill, California, United States, 94523
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Location
GSK Investigational Site
Hamilton, Ontario, Canada, L8V 5C2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Westwood, Kansas, United States, 66205
Status
Study Complete
Location
GSK Investigational Site
Lakeland, Florida, United States, 33805
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64154
Status
Study Complete
Location
GSK Investigational Site
Duarte, California, United States, 91010-3000
Status
Study Complete
Location
GSK Investigational Site
Galesburg, Illinois, United States, 61401
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2H1
Status
Study Complete
Location
GSK Investigational Site
Glendale, Arizona, United States, 85304
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89106
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Montreal, Québec, Canada, H2L 4M1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Moncton, New Brunswick, Canada, E1C 8X3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
London, Ontario, Canada, N6A 4L6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Location
GSK Investigational Site
Paducah, Kentucky, United States, 42003
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Aurora, Colorado, United States, 80012
Status
Study Complete
Location
GSK Investigational Site
Everett, Washington, United States, 98201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bedford, Texas, United States, 76022
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Dallas, Texas, United States, 75320-2510
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29403
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68510
Status
Study Complete
Location
GSK Investigational Site
Sugarland, Texas, United States, 77479
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Corpus Christi, Texas, United States, 78412
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-12-07
Actual study completion date
2012-12-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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