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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00390806
First received: October 19, 2006
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  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
Lung Cancer, Non-Small Cell
 Drug: HYCAMTIN, oral capsules
Radiation: Radiation
 Phase 3

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:

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: January 2013
Primary Completion Date: July 2012 (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 88 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00390806     History of Changes
Other Study ID Numbers: HYT105962
Study First Received: October 19, 2006
Last Updated: January 31, 2013
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 of the Russian Federation
Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Brain metastases from Non-Small Cell Lung Cancer
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
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 June 18, 2013