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Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma
This study has been completed.
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00044564
  Purpose

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 Intervention Phase
Carcinoma, Renal Cell
Drug: Bay 59-8862
Phase II

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Bayer:

Estimated Enrollment: 140
Study Start Date: December 2001
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044564

Locations
United States, California
Scripps Clinic & Research Foundation
La Jolla, California, United States, 92037
United States, Indiana
Medical Consultants, PC
Muncie, Indiana, United States, 47304
United States, Louisiana
Ochsner Foundation Hospital
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland Hospital Sys.
Baltimore, Maryland, United States, 21201-1595
Urology Associates
Greenbelt, Maryland, United States, 20770
United States, Michigan
Providence Hospital
Southfield, Michigan, United States, 48075
Harper Hospital
Detroit, Michigan, United States, 48201-9027
United States, Missouri
Washington University
St. Louis, Missouri, United States, 630
St Louis University HSC
St. Louis, Missouri, United States, 63104
United States, Montana
Billings Oncology Associates
Billings, Montana, United States, 59101
United States, New Jersey
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Bayer
  More Information

Study ID Numbers: Protocol No. 100386
Study First Received: August 30, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00044564  
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Taxane, Renal Cell Carcinoma
Advanced Renal Cell Carcinoma

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Taxane
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009