Trial Condition(s):

Carcinoma, Renal Cell

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

Bayer Identifier:

100386

ClinicalTrials.gov Identifier:

NCT00044564

EudraCT Number:

Not Available

Study Completed

Trial 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.

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.

Trial Summary

Enrollment Goal
54
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Cytotoxic Taxane (BAY59-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Calgary, Canada, T2N 4N2

Status
Completed
 
Locations

Investigative Site

München, Germany, 81675

Status
Completed
 
Locations

Investigative Site

Edmonton, Canada, T6G 1Z2

Status
Completed
 
Locations

Investigative Site

Manchester, United Kingdom, M20 4BX

Status
Completed
 
Locations

Investigative Site

La Jolla, United States, 92037

Status
Completed
 
Locations

Investigative Site

Salt Lake City, United States, 84112

Status
Completed
 
Locations

Investigative Site

Düsseldorf, Germany, 40225

Status
Completed
 
Locations

Investigative Site

CAEN CEDEX 5, France, 14076

Status
Completed
 
Locations

Investigative Site

Billings, United States, 59101

Status
Completed
 
Locations

Investigative Site

MONTPELLIER CEDEX, France, 34298

Status
Completed
 
Locations

Investigative Site

Heidelberg, Germany, 69112

Status
Completed
 
Locations

Investigative Site

Muncie, United States, 47304

Status
Completed
 

Trial Design