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Sponsored by: |
Theradex |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00039169 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have advanced kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: ortataxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | An Uncontrolled Phase II Multi-Center Trial Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Advanced Renal Cell Cancer |
Study Start Date: | December 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months thereafter or for up to 2 years.
PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced renal cell cancer
At least 1 measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No history of seizure disorder
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Patients with prior metastatic brain or meningeal tumors:
Radiotherapy:
Concurrent palliative radiotherapy allowed provided:
Surgery:
Other:
United States, California | |
Scripps Clinic | |
La Jolla, California, United States, 92037 | |
United States, Indiana | |
Medical Consultants | |
Muncie, Indiana, United States, 47303 | |
United States, Louisiana | |
Ochsner Clinic | |
New Orleans, Louisiana, United States, 70121 | |
United States, Maryland | |
206 Research Associates | |
Greenbelt, Maryland, United States, 20770 | |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Missouri | |
St. Louis University Health Sciences Center | |
Saint Louis, Missouri, United States, 63110-0250 | |
United States, Montana | |
Billings Oncology Associates | |
Billings, Montana, United States, 59101 | |
United States, New Jersey | |
Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08903 | |
United States, New York | |
State University of New York - Upstate Medical University | |
Syracuse, New York, United States, 13210 | |
United States, Utah | |
Huntsman Cancer Institute | |
Salt Lake City, Utah, United States, 84112 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 | |
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Tom Baker Cancer Center - Calgary | |
Calgary, Alberta, Canada, T2N 4N2 |
Study Chair: | Marius Moscovici, MD | Pharma-Clinical |
Study ID Numbers: | CDR0000069359, THERADEX-100386, BAYER-100386 |
Study First Received: | June 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00039169 History of Changes |
Health Authority: | United States: Federal Government |
stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer |
Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Recurrence Carcinoma Renal Cancer |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell |
Urogenital Neoplasms Kidney Diseases Urologic Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |