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This research study was designed to determine the effectiveness of the drug, topotecan, given intravenously (into a vein) together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of mixed mullerian origin. Additional purposes are to determine the long term outcome and side effects of this combination treatment.
Since topotecan and gemcitabine have different mechanisms of action, the combination of these 2 drugs may provide better results than either drug alone. Prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topotecan | Drug | |||
| Gemcitabine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| response rate |
| Measure | Description | Time Frame |
|---|---|---|
| response duration time to response time to progression survival safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD, PhD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Los Gatos | California | 95032 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| A website where viewers can complete a clinical study-matching questionnaire and also sign up for future study notification and healthcare newsletters. | View source |
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| Santa Rosa |
| California |
| 95403 |
| United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20010 | United States |
| GSK Investigational Site | Hollywood | Florida | 33021 | United States |
| GSK Investigational Site | Columbus | Georgia | 31902 | United States |
| GSK Investigational Site | Hinsdale | Illinois | 60521 | United States |
| GSK Investigational Site | Lansing | Michigan | 48912 | United States |
| GSK Investigational Site | Southfield | Michigan | 48075 | United States |
| GSK Investigational Site | Hattiesburg | Mississippi | 39401 | United States |
| GSK Investigational Site | Saint Louis | Montana | 63117 | United States |
| GSK Investigational Site | Rochester | New York | 14620 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599-7570 | United States |
| GSK Investigational Site | Abington | Pennsylvania | 19001-3788 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29601 | United States |
| GSK Investigational Site | Chattanooga | Tennessee | 37403 | United States |
| GSK Investigational Site | Calgary | Alberta | T2N 4N2 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1H 1C4 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4N 3M5 | Canada |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| D019772 | Topotecan |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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