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Home > "E" Clinical Trials Conditions > Epothilone B in Treating Patients With Advanced Kidney Cancer  Epothilone B in Treating Patients With Advanced Kidney Cancer
Epothilone B in Treating Patients With Advanced Kidney Cancer
For Condition: renal clear cell carcinoma,stage 4 renal cell cancer,stage 3 renal cell cancer,recurrent renal cell cancer
Status: Completed
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertFiglin, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-5907
United States
Additional Information:
Study ID Numbers: CDR0000069433; NCI-G02-2091,NOVARTIS-CEP0906A2207,UCLA-0202045
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041002
Other Stage 3 Renal Cell Cancer Studies:
1. Lymphocyte Therapy in Treating Patients With Kidney Cancer
2. AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
3. Rebeccamycin Analog in Treating Patients With Advanced Kidney Cancer
4. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
5. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
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Epothilone B in Treating Patients With Advanced Kidney Cancer
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