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Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044564
Recruitment Status : Completed
First Posted : September 4, 2002
Last Update Posted : December 19, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: Bay 59-8862 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma
Study Start Date : December 2001
Actual Study Completion Date : January 2003

Arm Intervention/treatment
Experimental: Arm 1 Drug: Bay 59-8862
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

Primary Outcome Measures :
  1. Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses [ Time Frame: At baseline and every 2 cycles during the treatment period ]

Secondary Outcome Measures :
  1. Duration of response [ Time Frame: At baseline and every cycle during the treatment period ]
  2. Overall survival [ Time Frame: Till end of follow up period (up to 2 years) ]
  3. Time to progression [ Time Frame: Throughout study ]
  4. Pharmacokinetics assessment [ Time Frame: At cycle 1 ]
  5. Qualitative and quantitative toxicity profile [ Time Frame: Day 1 of each cycle or as clinically indicated ]
  6. Physical examinations [ Time Frame: As clinically indicated ]
  7. Vital signs data [ Time Frame: Throughout study period ]
  8. Abnormal laboratory tests [ Time Frame: Prior to every cycle till last study visit ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00044564

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United States, California
La Jolla, California, United States, 92037
United States, Indiana
Muncie, Indiana, United States, 47304
United States, Louisiana
New Orleans, Louisiana, United States, 70121-2484
United States, Maryland
Baltimore, Maryland, United States, 21201-1595
Greenbelt, Maryland, United States, 20770
United States, Michigan
Detroit, Michigan, United States, 48201-9027
Southfield, Michigan, United States, 48075
United States, Missouri
St. Louis, Missouri, United States, 63104
St. Louis, Missouri, United States, 63110
United States, Montana
Billings, Montana, United States, 59101
United States, New Jersey
New Brunswick, New Jersey, United States, 08901
United States, Utah
Salt Lake City, Utah, United States, 84108
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Sudbury, Ontario, Canada, P3E 5J1
Caen Cedex 5, France, 14076
Montpellier Cedex, France, 34298
Heidelberg, Baden-Württemberg, Germany, 69120
Tübingen, Baden-Württemberg, Germany, 72076
München, Bayern, Germany, 81377
München, Bayern, Germany, 81675
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Münster, Nordrhein-Westfalen, Germany, 48149
Rotterdam, Netherlands, 3015 GD
United Kingdom
Plymouth, Devon, United Kingdom, PL6 8DH
Manchester, Greater Manchester, United Kingdom, M20 4BX
Cardiff, South Glamorgan, United Kingdom, CF14 2TL
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT00044564    
Other Study ID Numbers: 100386
First Posted: September 4, 2002    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Renal Cell Carcinoma
Advanced Renal Cell Carcinoma
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
IDN 5109
Antineoplastic Agents