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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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
Unnamed facility
La Jolla, California, United States
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
Duration of response
Time frame: At baseline and every cycle during the treatment period
Overall survival
Time frame: Till end of follow up period (up to 2 years)
Time to progression
Time frame: Throughout study
Pharmacokinetics assessment
Time frame: At cycle 1
Qualitative and quantitative toxicity profile
Time frame: Day 1 of each cycle or as clinically indicated
Physical examinations
Time frame: As clinically indicated
Vital signs data
Time frame: Throughout study period
Abnormal laboratory tests
Time frame: Prior to every cycle till last study visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Muncie, Indiana, United States
Unnamed facility
New Orleans, Louisiana, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Greenbelt, Maryland, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Southfield, Michigan, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Billings, Montana, United States
...and 19 more locations