Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:August 2003
End Date:August 2007

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An Open-Label, Multicenter, Randomized, Phase III Study Comparing Combination IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Advanced (IIIB/IV) Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to compare the efficacy and safety of a weekly regimen of two
FDA approved drugs in combination versus one FDA approved drug in subjects with advanced
non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or
HYCAMTIN.


Inclusion criteria:

- Written informed consent

- At least 18 years old

- Confirmed advanced non-small cell lung carcinoma (NSCLC)

- Received one prior chemotherapy for metastatic NSCLC excluding TAXOTERE or HYCAMTIN.
In addition, subjects are allowed to have previously received a non-cytotoxic therapy,
such as an endothelial growth factor receptor (EGFR) or angiogenesis inhibitor.

- Presence of either measurable or non-measurable disease by radiologic study or
physical examination.

- Full recovery and at least 21 days from prior treatment for NSCLC; 42 days from
treatment with mitomycin or nitrosureas and 30 days from prior non-cytotoxic therapy.

- At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in
the best interest of the patient).

- At least 7 days since prior radiotherapy.

- A probable life expectance of at least 3 months.

- Adequate bone marrow reserve, CBC/Platelet, kidney and liver function.

Exclusion criteria:

- Concomitant malignancies or other malignancies within the last five years.

- Symptoms of brain metastases requiring treatment with steroids.

- Active infection.

- Severe medical problems other than the diagnosis of NSCLC that would limit the ability
of the subject to follow study guidelines or expose the subject to extreme risk.

- Ongoing or planned chemotherapy (other than treatment during this study),
immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.

- Use of investigational drug within 30 days or 5 half-lives prior to the first dose of
study medication.

- Women who are pregnant or lactating.

- Subjects of child-bearing potential refusing to practice adequate contraception.

- Prior treatment with or history of allergic reaction to either HYCAMTIN or TAXOTERE.

- Subjects who cannot receive steroid premedication.
We found this trial at
62
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Elk Grove Village, Illinois 60007
1713
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Elk Grove Village, IL
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Abingdon, Virginia 24210
2025
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Abingdon, VA
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Baton Rouge, Louisiana 70809
1589
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Baton Rouge, LA
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Boca Raton, Florida 33486
2311
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Boca Raton, FL
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Boston, Massachusetts 02115
2578
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Boston, MA
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Bronx, New York 10461
2441
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Bronx, NY
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Buffalo, New York 14263
2181
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Buffalo, NY
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Calgary, Alberta
1189
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Calgary,
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Canton, Ohio 44708
2043
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Canton, OH
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Casper, Wyoming 82609
875
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Columbia, South Carolina 29203
2102
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Columbus, Georgia 31904
1901
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Columbus, GA
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Decatur, Illinois 62526
1645
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Decatur, IL
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Denver, Colorado 80206
819
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Denver, CO
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Dunmore, Pennsylvania 18512
2345
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Dunmore, PA
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East Syracuse, New York 13057
2322
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East Syracuse, NY
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Fayetteville, North Carolina 28304
2213
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Fayetteville, NC
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Frederick, Maryland 21702
2258
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Frederick, MD
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Fresno, California 93720
216
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Grosse Point Woods, Michigan 48236
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Grosse Point Woods, MI
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Hackensack, New Jersey 07601
2430
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Hackensack, NJ
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Hilton Head Island, South Carolina 29926
2148
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Hilton Head Island, SC
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Huntsville, Alabama 35801
1786
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Indianapolis, Indiana 46202
1793
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Indianapolis, IN
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Irving, Texas 75039
1214
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Irving, TX
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Knoxville, Tennessee 37916
1923
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Lafayette, Louisiana 70503
1537
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Lafayette, LA
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Lake Charles, Louisiana 70601
1471
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Lake Charles, LA
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Lakeland, Florida 33805
2163
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Lakeland, FL
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Las Vegas, Nevada 89102
214
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Las Vegas, NV
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Little Rock, Arkansas 72205
1459
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Little Rock, AR
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Los Angeles, California 90025
24
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Louisville, Kentucky 40202
1813
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Manhasset, New York 11030
2448
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Manhasset, NY
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Miami Shores, Florida 33138
2319
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Miami Shores, FL
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Milwaukee, Wisconsin 53215
1726
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Milwaukee, WI
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Minneapolis, Minnesota 55404
1509
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Minneapolis, MN
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Mobile, Alabama 36617
1754
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Mobile, AL
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Nashville, Tennessee 37203
1762
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New Hyde Park, New York 11040
2449
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Norfolk, Virginia 23502
2341
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Nyack, New York 10960
2435
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Nyack, NY
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Orange Park, Florida 32073
2130
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Orlando, Florida 32806
2186
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Philadelphia, Pennsylvania 19104
2373
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Poway, California 92064
95
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Reno, Nevada 89502
385
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Reno, NV
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Robbinsdale, Minnesota 55422
1508
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Rochester, New York 14642
2244
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Rochester, NY
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Sheboygan, Wisconsin 53081
1748
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Skokie, Illinois 60076
1726
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Spartanburg, South Carolina 29303
2042
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Spokane, Washington 99208
947
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Springfield, Missouri 65807
1398
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St. Louis, Missouri 63110
1570
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Stuart, Florida 34994
2281
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Tacoma, Washington 98405
939
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Tucson, Arizona 85724
427
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Tyler, Texas 75702
1314
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Urbana, Illinois 61801
1686
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Washington, District of Columbia 20007
2281
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Winston-Salem, North Carolina 27103
2122
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