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| ID | Type | Description | Link |
|---|---|---|---|
| 307979 | Other Identifier | company internal |
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The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with carboplatin in patients with recurrent ovarian cancer, who previously have had a good response with cisplatin or carboplatin, is safe and helps to decrease or stop tumor growth.
This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc. is sponsoring this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sagopilone (ZK 219477) + carboplatin | Drug | Chemotherapy for recurrent ovarian cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response to treatment with ZK-Epo after 6 cycles | After 6 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of ZK-Epo given with carboplatin | Sept. 2008 |
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Inclusion Criteria:- Must have evidence of ovarian cancer measurable by computed tomography (CT) scan or by CA125 blood levels- No radiation therapy in last 4 weeks- No chemotherapy in last 24 weeks - No immunotherapy in last 4 weeks- Good response after previous treatment with carboplatin or cisplatin and then the ovarian cancer got worse again after at least 6 months- Additional criteria determined at screening visit Exclusion Criteria:- Having had more than one treatment regimen with carboplatin or cisplatin- Prior treatment with other epothilones (e.g. ixabepilone)- Use of any investigational drug in the last 4 weeks- Previous radiation to the whole pelvis- Symptomatic brain tumors requiring radiation to the brain - Active infection- Pregnant or breast feeding- Additional criteria determined at screening visit
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85724 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22108514 | Result | McMeekin S, Patel R, Verschraegen C, Celano P, Burke J 2nd, Plaxe S, Ghatage P, Giurescu M, Stredder C, Wang Y, Schmelter T. Phase I/II study of sagopilone (ZK-EPO) plus carboplatin in women with recurrent platinum-sensitive ovarian cancer. Br J Cancer. 2012 Jan 3;106(1):70-6. doi: 10.1038/bjc.2011.499. Epub 2011 Nov 22. |
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| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Bakersfield | California | 93309 | United States |
| La Jolla | California | 92093 | United States |
| San Diego | California | 92121 | United States |
| Savannah | Georgia | 31404 | United States |
| South Bend | Indiana | 46617 | United States |
| Baltimore | Maryland | 21204 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Cleveland | Ohio | 44109 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Knoxville | Tennessee | 37920 | United States |
| Roanoke | Virginia | 24014 | United States |
| Calgary | Alberta | T2N 4N2 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| C530494 | sagopilone |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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