Carcinoma, Renal Cell
Conditions
Keywords
Taxane, Renal Cell Carcinoma, Advanced Renal Cell Carcinoma
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.
Interventions
DRUGBay 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
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | Till end of follow up period (up to 2 years) |
| Time to progression | Throughout study |
| Pharmacokinetics assessment | At cycle 1 |
| Duration of response | At baseline and every cycle during the treatment period |
| Physical examinations | As clinically indicated |
| Vital signs data | Throughout study period |
| Abnormal laboratory tests | Prior to every cycle till last study visit |
| Qualitative and quantitative toxicity profile | Day 1 of each cycle or as clinically indicated |
Countries
Canada, France, Germany, Netherlands, United Kingdom, United States
Outcome results
None listed