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In patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered to be radioresistant and chemoresistant. In patients with metastatic disease, the options are limited. The taxanes are among the most commonly used class of chemotherapy agents in clinical oncology today but they are not effective in renal cancers; the development of Bay 59-8862 targets taxane-resistant tumors and the current protocol is designed to test the safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bay 59-8862 | Drug | 75 mg/m2 of BAY 59-8862 intravenously over one hour. Treatment will be repeated once every 3 weeks and tumor measurements will be made every 2 cycles till progression, unacceptable toxicity or consent withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses | At baseline and every 2 cycles during the treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response | At baseline and every cycle during the treatment period | |
| Overall survival | Till end of follow up period (up to 2 years) | |
| Time to progression |
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Inclusion Criteria: - measurable disease as defined by the presence of at least one measurable lesion - prior immunotherapy (up to 2 regimens) or prior radiotherapy is permitted but at least 4 weeks must have elapsed prior to enter study - life expectancy of at least 12 weeks - adequate bone marrow, liver and kidney function Exclusion Criteria: - excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, brain metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers - excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant - others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla | California | 92037 | United States | |||
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| Throughout study |
| Pharmacokinetics assessment | At cycle 1 |
| Qualitative and quantitative toxicity profile | Day 1 of each cycle or as clinically indicated |
| Physical examinations | As clinically indicated |
| Vital signs data | Throughout study period |
| Abnormal laboratory tests | Prior to every cycle till last study visit |
| Muncie |
| Indiana |
| 47304 |
| United States |
| New Orleans | Louisiana | 70121-2484 | United States |
| Baltimore | Maryland | 21201-1595 | United States |
| Greenbelt | Maryland | 20770 | United States |
| Detroit | Michigan | 48201-9027 | United States |
| Southfield | Michigan | 48075 | United States |
| St Louis | Missouri | 63104 | United States |
| St Louis | Missouri | 63110 | United States |
| Billings | Montana | 59101 | United States |
| New Brunswick | New Jersey | 08901 | United States |
| Salt Lake City | Utah | 84108 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Calgary | Alberta | T2N 4N2 | Canada |
| Edmonton | Alberta | T6G 1Z2 | Canada |
| Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Caen | 14076 | France |
| Montpellier | 34298 | France |
| Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Tübingen | Baden-Wurttemberg | 72076 | Germany |
| München | Bavaria | 81377 | Germany |
| München | Bavaria | 81675 | Germany |
| Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Münster | North Rhine-Westphalia | 48149 | Germany |
| Rotterdam | 3015 GD | Netherlands |
| Plymouth | Devon | PL6 8DH | United Kingdom |
| Manchester | Greater Manchester | M20 4BX | United Kingdom |
| Cardiff | South Glamorgan | CF14 2TL | United Kingdom |
| Sutton | Surrey | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C404743 | IDN 5109 |
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