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| Sponsor: | Jonsson Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00040989 |
Purpose
RATIONALE: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent, unresectable, or metastatic kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Stage IV Renal Cell Cancer Recurrent Renal Cell Cancer |
Drug: BAY 56-3722 Procedure: enzyme inhibitor therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive BAY 56-3722 IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 26 Study Locations| Study Chair: | Barbara J. Gitlitz, MD | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000069432, UCLA-0201019, UTHSC-0125011152, BAYER-100364, NCI-G02-2090 |
| Study First Received: | July 8, 2002 |
| Last Updated: | January 11, 2007 |
| ClinicalTrials.gov Identifier: | NCT00040989 History of Changes |
| Health Authority: | United States: Federal Government |
|
Disease Attributes Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Urogenital Neoplasms Urologic Neoplasms Pharmacologic Actions Recurrence Carcinoma |
Neoplasms Pathologic Processes Neoplasms by Site Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |