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| Sponsor: | Jonsson Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00041002 |
Purpose
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 epothilone B in treating patients who have advanced kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: epothilone B |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | An Open Label Phase IIa Trial Evaluating The Safety And Efficacy Of EP0906 As Therapy In Patients With Advanced Renal Cancer |
| Study Start Date: | April 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive epothilone B IV over 5 minutes once weekly for three weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 week and then every three months thereafter.
PROJECTED ACCRUAL: Approximately 48 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:
Histologically or cytologically confirmed epithelial renal cell carcinoma
At least one measurable lesion
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| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-5907 | |
| Study Chair: | Robert A. Figlin, MD, FACP | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000069433, UCLA-0202045, NOVARTIS-CEP0906A2207, NCI-G02-2091 |
| Study First Received: | July 8, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00041002 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer clear cell renal cell carcinoma |
|
Epothilone B Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Epothilones Mitosis Modulators Urogenital Neoplasms Antimitotic Agents Urologic Neoplasms Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Tubulin Modulators Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |