Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00390806

Purpose

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.

Condition	Intervention	Phase
Brain Metastases From Non-Small Cell Lung Cancer Lung Cancer, Non-Small Cell	Drug: HYCAMTIN, oral capsules Radiation: Radiation	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Lung Cancer

Drug Information available for: Topotecan hydrochloride Topotecan

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Overall survival [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lesion assessment and measurement (baseline; Day 21, Day 28 of both phases) Brain tumor symptom assessment (baseline; Day 1 - 28 of both phases) Adverse events Laboratory tests Disease-related events or outcomes [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
6-month survival rate [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
response rate [central nervous system (CNS)-radiologic] [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
time to response (CNS-radiologic) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
time to progression (CNS-radiologic) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
time to progression (all sites-radiologic) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
safety and tolerability (as measured by AE monitoring) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]

Enrollment:	473
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: topotecan plus radiation topotecan 1.1 mg/m2 followed by whole brain radiation 3 Gy/day for 10 days, followed by optional continuation therapy with topotecan 2.3 mg/m2 for 5 days Q21 days as monotherapy.	Drug: HYCAMTIN, oral capsules topotecan oral capsules 1.1 mg/m2 Other Names: HYCAMTIN oral capsules Radiation: Radiation Whole brain radiation
Active Comparator: Whole brain radiation Whole brain radiation 3 Gy/day for 10 days	Radiation: Radiation Whole brain radiation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390806

Show 81 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00390806 History of Changes
Other Study ID Numbers:	HYT105962
Study First Received:	October 19, 2006
Last Updated:	October 6, 2011
Health Authority:	Slovakia: State Institute for Drug Control; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Poland:; Hungary: National Institute of Pharmacy; Russia: Ministry of Health and Social Development of the Russian Federation; Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Brain metastases brain tumor lung cancer oral chemotherapy HYCAMTIN topotecan NSCLC WBRT whole brain radiation

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes

Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012