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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00061308 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer |
Drug: Topotecan Drug: Gemcitabine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Safety/Efficacy Study |
| Official Title: | An Open-Label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-Line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| GSK Investigational Site | |
| Los Gatos, California, United States, 95032 | |
| GSK Investigational Site | |
| Santa Rosa, California, United States, 95403 | |
| United States, District of Columbia | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| GSK Investigational Site | |
| Hollywood, Florida, United States, 33021 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Columbus, Georgia, United States, 31902 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Hinsdale, Illinois, United States, 60521 | |
| United States, Michigan | |
| GSK Investigational Site | |
| Southfield, Michigan, United States, 48075 | |
| GSK Investigational Site | |
| Lansing, Michigan, United States, 48912 | |
| United States, Mississippi | |
| GSK Investigational Site | |
| Hattiesburg, Mississippi, United States, 39401 | |
| United States, Montana | |
| GSK Investigational Site | |
| St. Louis, Montana, United States, 63117 | |
| United States, New York | |
| GSK Investigational Site | |
| Rochester, New York, United States, 14620 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Chapel Hill, North Carolina, United States, 27599-7570 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Abington, Pennsylvania, United States, 19001-3788 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Greenville, South Carolina, United States, 29601 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Chattanooga, Tennessee, United States, 37403 | |
| Canada, Alberta | |
| GSK Investigational Site | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| GSK Investigational Site | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Ontario | |
| GSK Investigational Site | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Study Director: | GSK Clinical Trials, MD, PhD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 104864/627 |
| Study First Received: | May 23, 2003 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00061308 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
Ovarian cancer Fallopian cancer peritoneal cancer cancer |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Gemcitabine |
Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Abdominal Neoplasms Immunosuppressive Agents Antiviral Agents Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases |