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

NCT00390806 | Completed Phase 3 Results DMC

• 1 other identifier: HYT105962
• Study Type: interventional
• Target: 472
• Locations: 6 countries
• Sites: 88

Brief 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.

Conditions

Lung Cancer, Non-Small Cell

Keywords

Brain metastases from Non-Small Cell Lung Cancer; Brain metastases brain tumor lung cancer oral chemotherapy HYCAMTIN topotecan NSCLC WBRT whole brain radiation

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival is defined as the time from randomization until the date of death due to any cause. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.

  From the time of Randomization until the date of death due to any cause (up to 195 weeks)

Secondary Outcomes (30)

• Six-month Survival

  Month 6

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

  From the time of Randomization until the time of CR or PR (up to 75 weeks)

• Time to Response (TTR) (CNS-radiologic)

  From the time of Randomization until the first documented evidence of CR or PR (up to 75 weeks)

• Time to Progression (TTP) (CNS-radiologic)

  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)

  From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)

Study Arms (2)

topotecan plus radiation

EXPERIMENTAL

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; Radiation: Radiation

Whole brain radiation

ACTIVE COMPARATOR

Whole brain radiation 3 Gy/day for 10 days

Radiation: Radiation

Interventions

HYCAMTIN, oral capsules DRUG

topotecan oral capsules 1.1 mg/m2

Also known as: HYCAMTIN, oral capsules

topotecan plus radiation

Radiation RADIATION

Whole brain radiation

Whole brain radiation; topotecan plus radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (88)

GSK Investigational Site

Birmingham, Alabama, 35294, United States

Location

GSK Investigational Site

Glendale, Arizona, 85304, United States

Location

GSK Investigational Site

Hot Springs, Arkansas, 71913, United States

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GSK Investigational Site

Anaheim, California, 92801, United States

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GSK Investigational Site

Duarte, California, 91010-3000, United States

Location

GSK Investigational Site

Pleasant Hill, California, 94523, United States

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GSK Investigational Site

Aurora, Colorado, 80012, United States

Location

GSK Investigational Site

Lakeland, Florida, 33805, United States

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GSK Investigational Site

Tampa, Florida, 33606, United States

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GSK Investigational Site

Tampa, Florida, 33612, United States

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GSK Investigational Site

Chicago, Illinois, 60612, United States

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GSK Investigational Site

Elk Grove Village, Illinois, 60007, United States

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GSK Investigational Site

Galesburg, Illinois, 61401, United States

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GSK Investigational Site

Park Ridge, Illinois, 60068, United States

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GSK Investigational Site

Rockford, Illinois, 61108, United States

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GSK Investigational Site

Skokie, Illinois, 60077, United States

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GSK Investigational Site

Indianapolis, Indiana, 46227, United States

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GSK Investigational Site

Westwood, Kansas, 66205, United States

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GSK Investigational Site

Paducah, Kentucky, 42003, United States

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GSK Investigational Site

Metairie, Louisiana, 70006, United States

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GSK Investigational Site

Minneapolis, Minnesota, 55455, United States

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GSK Investigational Site

Jackson, Mississippi, 39216, United States

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GSK Investigational Site

Columbia, Missouri, 65201, United States

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GSK Investigational Site

Kansas City, Missouri, 64154, United States

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GSK Investigational Site

Lincoln, Nebraska, 68510, United States

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GSK Investigational Site

Las Vegas, Nevada, 89106, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89135, United States

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GSK Investigational Site

Albuquerque, New Mexico, 87109, United States

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GSK Investigational Site

Albany, New York, 12206, United States

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GSK Investigational Site

Buffalo, New York, 14215-1199, United States

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GSK Investigational Site

Buffalo, New York, 14215, United States

Location

GSK Investigational Site

The Bronx, New York, 10467, United States

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GSK Investigational Site

Columbus, Ohio, 43235, United States

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GSK Investigational Site

Eugene, Oregon, 97401-8122, United States

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GSK Investigational Site

Charleston, South Carolina, 29403, United States

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GSK Investigational Site

Bedford, Texas, 76022, United States

Location

GSK Investigational Site

Corpus Christi, Texas, 78412, United States

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GSK Investigational Site

Dallas, Texas, 75320-2510, United States

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GSK Investigational Site

Duncanville, Texas, 75137, United States

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GSK Investigational Site

Fort Worth, Texas, 76104, United States

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GSK Investigational Site

Lubbock, Texas, 79415, United States

Location

GSK Investigational Site

Sherman, Texas, 75090, United States

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GSK Investigational Site

Sugarland, Texas, 77479, United States

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GSK Investigational Site

Everett, Washington, 98201, United States

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GSK Investigational Site

Vancouver, Washington, 98684, United States

Location

GSK Investigational Site

Madison, Wisconsin, 53792, United States

Location

GSK Investigational Site

Moncton, New Brunswick, E1C 8X3, Canada

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GSK Investigational Site

Hamilton, Ontario, L8V 5C2, Canada

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GSK Investigational Site

Kingston, Ontario, K7L 5P9, Canada

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GSK Investigational Site

London, Ontario, N6A 4L6, Canada

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GSK Investigational Site

Toronto, Ontario, M5G 2M9, Canada

Location

GSK Investigational Site

Greenfield Park, Quebec, J4V 2H1, Canada

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GSK Investigational Site

Montreal, Quebec, H1T 2M4, Canada

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GSK Investigational Site

Montreal, Quebec, H2L 4M1, Canada

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GSK Investigational Site

Québec, Quebec, G1R 2J6, Canada

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GSK Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

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GSK Investigational Site

Budapest, 1529, Hungary

Location

GSK Investigational Site

Csorna, 9300, Hungary

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GSK Investigational Site

Győr, 9024, Hungary

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GSK Investigational Site

Gyula, 5703, Hungary

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GSK Investigational Site

Mátraháza, 3233, Hungary

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GSK Investigational Site

Miskolc, 3529, Hungary

Location

GSK Investigational Site

Nyíregyháza, 4400, Hungary

Location

GSK Investigational Site

Pécs, 7623, Hungary

Location

GSK Investigational Site

Székesfehérvár, 8000, Hungary

Location

GSK Investigational Site

Szombathely, 9700, Hungary

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GSK Investigational Site

Törökbálint, 2045, Hungary

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GSK Investigational Site

Zalaegerszeg-Pozva, 8900, Hungary

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GSK Investigational Site

Bialystok, 15-540, Poland

Location

GSK Investigational Site

Bydgoszcz, 85-769, Poland

Location

GSK Investigational Site

Gdansk, 80-211, Poland

Location

GSK Investigational Site

Krakow, 31-115, Poland

Location

GSK Investigational Site

Olsztyn, 10-226, Poland

Location

GSK Investigational Site

Olsztyn, 10-357, Poland

Location

GSK Investigational Site

Poznan, 60-569, Poland

Location

GSK Investigational Site

Kazan', 420111, Russia

Location

GSK Investigational Site

Moscow, 105229, Russia

Location

GSK Investigational Site

Moscow, 115 478, Russia

Location

GSK Investigational Site

Moscow, 128128, Russia

Location

GSK Investigational Site

Moscow, 129 128, Russia

Location

GSK Investigational Site

Obninsk, 249036, Russia

Location

GSK Investigational Site

Orenburg, 460021, Russia

Location

GSK Investigational Site

Saint Petersburg, 197022, Russia

Location

GSK Investigational Site

Saint Petersburg, 197758, Russia

Location

GSK Investigational Site

Voronezh, 394062, Russia

Location

GSK Investigational Site

Banská Bystrica, 975 17, Slovakia

Location

GSK Investigational Site

Bratislava, 826 06, Slovakia

Location

GSK Investigational Site

Nitra, 949 01, Slovakia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Topotecan; Capsules; Radiation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Physical Phenomena

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 20, 2006
• Study Start: December 1, 2006
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2013
• Last Updated: January 20, 2014
• Results First Posted: January 20, 2014

Record last verified: 2013-12

Locations

RU (10); US (46); SL (3); CA (10); HU (12); PL (7)