Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- 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 ]
| Enrollment: | 140 |
| Study Start Date: | December 2001 |
| Study Completion Date: | January 2003 |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Show 29 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bayer HealtCare Pharmaceuticals Inc., Therapeutic Area Head |
| ClinicalTrials.gov Identifier: | NCT00044564 History of Changes |
| Other Study ID Numbers: | 100386 |
| Study First Received: | August 30, 2002 |
| Last Updated: | June 21, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Taxane Renal Cell Carcinoma Advanced Renal Cell Carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013