The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)



Status:Completed
Conditions:Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/1/2017
Start Date:August 2002

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A Phase II Trial of Twice Daily Oral Topotecan as a Radiation Sensitizer With Twice Daily Radiotherapy for Newly Diagnosed Small Cell Lung Cancer

This study will gather information on the effectiveness and safety of a treatment program
for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination,
radiation therapy, and an oral investigational drug that may enhance the effects of
radiation therapy. Study patients will receive two additional courses of the standard
chemotherapy combination after completing radiation therapy.


Inclusion Criteria:

- Patients must have newly diagnosed, limited stage SCLC (small cell lung cancer), with
no prior radiotherapy. Patients are allowed to have had a resection or biopsy.

- Women of reproductive potential must have a negative serum pregnancy test at the
study screening visit.

- Patients must give written informed consent to participate in the study.

- Patients must be able to take oral medication.

- Patients should be completely recovered from recent surgery.

- Laboratory criteria: Patients must have adequate bone marrow reserve and adequate
kidney and liver function.

- Patients must be evaluated by the radiation oncologist prior to study entry.

Exclusion Criteria:

- Extensive Stage SCLC.

- Women who are pregnant or lactating.

- Use of an investigational drug within 30 days prior to the first dose of study
medication.

- Any medically/clinically significant active infection.

- Symptoms of the SCLC spreading to the brain.

- Patients with limited stage SCLC who have undergone complete resection with no
measurable disease prior to starting chemotherapy.

- Severe medical problems, unrelated to SCLC, that would limit the patient's full
ability to follow all study rules and procedures, or that would expose the patient to
extreme risk.

- Other ongoing, immunotherapy or radiotherapy being administered at the time as study
participation.
We found this trial at
30
sites
Toledo, Ohio 43608
121
mi
from 43215
Toledo, OH
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Akron, Ohio 44313
111
mi
from 43215
Akron, OH
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Albuquerque, New Mexico 87109
1327
mi
from 43215
Albuquerque, NM
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Bakersfield, California 93309
1982
mi
from 43215
Bakersfield, CA
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Cincinnati, Ohio 45229
96
mi
from 43215
Cincinnati, OH
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Cleveland, Ohio 44195
129
mi
from 43215
Cleveland, OH
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Duluth, Minnesota 55805
655
mi
from 43215
Duluth, MN
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Fort Worth, Texas 76104
937
mi
from 43215
Fort Worth, TX
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Fountain Valley, California 92708
1966
mi
from 43215
Fountain Valley, CA
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Gainesville, Florida 32610
713
mi
from 43215
Gainesville, FL
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Green Bay, Wisconsin 54301
403
mi
from 43215
Green Bay, WI
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Indianapolis, Indiana 46202
166
mi
from 43215
Indianapolis, IN
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La Crosse, Wisconsin 54601
497
mi
from 43215
La Crosse, WI
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Lexington, Kentucky 40504
156
mi
from 43215
Lexington, KY
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Little Rock, Arkansas 72205
625
mi
from 43215
Little Rock, AR
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Los Angeles, California 90025
1983
mi
from 43215
Los Angeles, CA
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Madison, Wisconsin 53792
394
mi
from 43215
Madison, WI
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Milwaukee, Wisconsin 53215
329
mi
from 43215
Milwaukee, WI
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Minneapolis, Minnesota 55404
624
mi
from 43215
Minneapolis, MN
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New Orleans, Louisiana 70112
797
mi
from 43215
New Orleans, LA
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Phoenix, Arizona 85012
1660
mi
from 43215
Phoenix, AZ
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Raleigh, North Carolina 27614
366
mi
from 43215
Raleigh, NC
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Robbinsdale, Minnesota 55422
630
mi
from 43215
Robbinsdale, MN
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Saint Louis, Missouri 63110
397
mi
from 43215
Saint Louis, MO
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San Antonio, Texas 78258
1126
mi
from 43215
San Antonio, TX
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Scarborough, Maine 04074
696
mi
from 43215
Scarborough, ME
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Shreveport, Louisiana 71103
789
mi
from 43215
Shreveport, LA
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Springfield, Massachusetts 01199
562
mi
from 43215
Springfield, MA
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St. Louis, Montana 63110
?
mi
from 43215
St. Louis, MT
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Wausau, Wisconsin 54401
481
mi
from 43215
Wausau, WI
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