Expired Study
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Los Angeles, California 90095


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.


Study summary:

OBJECTIVES: - Determine whether epothilone B can produce a significant response (complete response (CR) or partial response (PR)) as measured by tumor shrinkage in patients with advanced renal cancer. - Determine the objective response rate and duration of response in patients with CR or PR after treatment with this drug. - Determine the time to disease progression and overall survival in patients treated with this drug. - Determine the safety and tolerability of this drug in these patients. - Determine genetic factors related to renal cancer that may predict response in patients treated with this drug. - Determine relative susceptibility to drug-drug interactions or serious side effects in patients treated with this drug. 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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed epithelial renal cell carcinoma - Clear cell - Sarcomatoid - Papillary - Medullary - Collecting duct - Chromophobe - Mixed histology - Progressive regional disease or metastatic disease - Prior nephrectomy required - Previously untreated patients or patients who have received no more than one prior cytokine regimen (interleukin-2, interferon alfa, or a combination of these agents) and have failed or relapsed within 8 months of treatment - At least one measurable lesion - Patients who have received prior radiotherapy to the marker lesion(s) must have disease progression in that lesion since treatment - No CNS metastases or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - WHO 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC greater than 3,000/mm^3 - Absolute neutrophil count greater than 1,500/mm^3 - Hemoglobin greater than 9.0 g/dL - Platelet count greater than 100,000/mm^3 - Red blood cell transfusions allowed Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present) - Alkaline phosphatase less than 2.5 times ULN Renal: - Creatinine less than 1.5 times ULN Cardiovascular: - No severe cardiac insufficiency - No New York Heart Association class III or IV disease - No uncontrolled and/or unstable cardiac or coronary artery disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 6 months after study therapy - No peripheral neuropathy greater than grade 1 - No unresolved diarrhea greater than grade 1 - No active or suspected acute or chronic uncontrolled infection - No abscess or fistula - HIV negative - No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer, prostate cancer, or carcinoma in situ of the cervix - No prior noncompliance to medical regimens - No history of severe medical conditions that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics Surgery: - See Disease Characteristics - At least 4 weeks since prior major surgery Other: - More than 28 days since prior investigational drugs - No other concurrent investigational drugs - No concurrent warfarin or other agents containing warfarin except low-dose warfarin (1 mg or less) administered prophylactically for maintenance of indwelling lines or ports


NCT ID:

NCT00041002


Primary Contact:

Study Chair
Robert A. Figlin, MD, FACP
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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