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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer, Non-Small Cell

Intervention: HYCAMTIN, oral capsules (Drug); Radiation (Radiation)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Survival

Secondary outcome:

Six-month Survival

Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic)

Time to Response (TTR) (CNS-radiologic)

Time to Progression (TTP) (CNS-radiologic)

Time to Progression (TTP) (All Sites of Disease-radiologic)

Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at 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

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at 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

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at 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

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at 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

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

Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at 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

Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at 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

Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at 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

Number of Participants With the Indicated Investigator Assessment of Sensation at 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

Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3

Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3

Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3

Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE)

Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range

Lesion Assessment and Measurement

Brain Symptoms

Number of Participants Who Died or Progressed

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Quebec G1R 2J6, Canada

GSK Investigational Site, Budapest 1529, Hungary

GSK Investigational Site, Csorna 9300, Hungary

GSK Investigational Site, Gyula 5703, Hungary

GSK Investigational Site, Győr 9024, Hungary

GSK Investigational Site, Miskolc 3529, Hungary

GSK Investigational Site, Mátraháza 3233, Hungary

GSK Investigational Site, Nyíregyháza 4400, Hungary

GSK Investigational Site, Pécs 7623, Hungary

GSK Investigational Site, Szombathely 9700, Hungary

GSK Investigational Site, Székesfehérvár 8000, Hungary

GSK Investigational Site, Törökbálint 2045, Hungary

GSK Investigational Site, Zalaegerszeg-Pozva 8900, Hungary

GSK Investigational Site, Bialystok 15-540, Poland

GSK Investigational Site, Bydgoszcz 85-769, Poland

GSK Investigational Site, Gdansk 80-211, Poland

GSK Investigational Site, Krakow 31-115, Poland

GSK Investigational Site, Olsztyn 10-226, Poland

GSK Investigational Site, Olsztyn 10-357, Poland

GSK Investigational Site, Poznan 60-569, Poland

GSK Investigational Site, Kazan 420111, Russian Federation

GSK Investigational Site, Moscow 105229, Russian Federation

GSK Investigational Site, Moscow 115 478, Russian Federation

GSK Investigational Site, Moscow 128128, Russian Federation

GSK Investigational Site, Moscow 129 128, Russian Federation

GSK Investigational Site, Obninsk 249036, Russian Federation

GSK Investigational Site, Orenburg 460021, Russian Federation

GSK Investigational Site, St-Petersburg 197758, Russian Federation

GSK Investigational Site, St. Petersburg 197022, Russian Federation

GSK Investigational Site, Voronezh 394062, Russian Federation

GSK Investigational Site, Banska Bystrica 975 17, Slovakia

GSK Investigational Site, Bratislava 826 06, Slovakia

GSK Investigational Site, Nitra 949 01, Slovakia

GSK Investigational Site, Birmingham, Alabama 35294, United States

GSK Investigational Site, Glendale, Arizona 85304, United States

GSK Investigational Site, Hot Springs, Arkansas 71913, United States

GSK Investigational Site, Anaheim, California 92801, United States

GSK Investigational Site, Duarte, California 91010-3000, United States

GSK Investigational Site, Pleasant Hill, California 94523, United States

GSK Investigational Site, Aurora, Colorado 80012, United States

GSK Investigational Site, Lakeland, Florida 33805, United States

GSK Investigational Site, Tampa, Florida 33612, United States

GSK Investigational Site, Tampa, Florida 33606, United States

GSK Investigational Site, Chicago, Illinois 60612, United States

GSK Investigational Site, Elk Grove Village, Illinois 60007, United States

GSK Investigational Site, Galesburg, Illinois 61401, United States

GSK Investigational Site, Park Ridge, Illinois 60068, United States

GSK Investigational Site, Rockford, Illinois 61108, United States

GSK Investigational Site, Skokie, Illinois 60077, United States

GSK Investigational Site, Indianapolis, Indiana 46227, United States

GSK Investigational Site, Westwood, Kansas 66205, United States

GSK Investigational Site, Paducah, Kentucky 42003, United States

GSK Investigational Site, Metairie, Louisiana 70006, United States

GSK Investigational Site, Minneapolis, Minnesota 55455, United States

GSK Investigational Site, Jackson, Mississippi 39216, United States

GSK Investigational Site, Columbia, Missouri 65201, United States

GSK Investigational Site, Kansas City, Missouri 64154, United States

GSK Investigational Site, Lincoln, Nebraska 68510, United States

GSK Investigational Site, Las Vegas, Nevada 89106, United States

GSK Investigational Site, Las Vegas, Nevada 89135, United States

GSK Investigational Site, Moncton, New Brunswick E1C 8X3, Canada

GSK Investigational Site, Albuquerque, New Mexico 87109, United States

GSK Investigational Site, Albany, New York 12206, United States

GSK Investigational Site, Bronx, New York 10467, United States

GSK Investigational Site, Buffalo, New York 14215-1199, United States

GSK Investigational Site, Buffalo, New York 14215, United States

GSK Investigational Site, Columbus, Ohio 43235, United States

GSK Investigational Site, Hamilton, Ontario L8V 5C2, Canada

GSK Investigational Site, Kingston, Ontario K7L 5P9, Canada

GSK Investigational Site, London, Ontario N6A 4L6, Canada

GSK Investigational Site, Toronto, Ontario M5G 2M9, Canada

GSK Investigational Site, Eugene, Oregon 97401-8122, United States

GSK Investigational Site, Greenfield Park, Quebec J4V 2H1, Canada

GSK Investigational Site, Montreal, Quebec H2L 4M1, Canada

GSK Investigational Site, Montreal, Quebec H1T 2M4, Canada

GSK Investigational Site, Sherbrooke, Quebec J1H 5N4, Canada

GSK Investigational Site, Charleston, South Carolina 29403, United States

GSK Investigational Site, Bedford, Texas 76022, United States

GSK Investigational Site, Corpus Christi, Texas 78412, United States

GSK Investigational Site, Dallas, Texas 75320-2510, United States

GSK Investigational Site, Duncanville, Texas 75137, United States

GSK Investigational Site, Fort Worth, Texas 76104, United States

GSK Investigational Site, Lubbock, Texas 79415, United States

GSK Investigational Site, Sherman, Texas 75090, United States

GSK Investigational Site, Sugarland, Texas 77479, United States

GSK Investigational Site, Everett, Washington 98201, United States

GSK Investigational Site, Vancouver, Washington 98684, United States

GSK Investigational Site, Madison, Wisconsin 53792, United States

Additional Information

Starting date: December 2006
Last updated: December 5, 2013

Page last updated: August 23, 2015

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