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

GSK study ID
HYT105962
See study documents
Clinicaltrials.gov ID
NCT00390806
See results summary
EudraCT ID
2006-002074-22
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2012-12-07
    Observational study model:
    Not applicable
    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
    • Inclusion criteria:
    • At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC)
    Inclusion and exclusion criteria
    Inclusion 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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Gyula, Hungary, 5703
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pécs, Hungary, 7623
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33612
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Albany, New York, United States, 12206
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Győr, Hungary, 9024
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89135
    Status
    Terminated/Withdrawn
    Contact us
    Showing 1 - 6 of 88 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website