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Home > "C" Clinical Trials Conditions > Chemotherapy in Treating Patients With Metastatic Kidney Cancer  Chemotherapy in Treating Patients With Metastatic Kidney Cancer
Chemotherapy in Treating Patients With Metastatic Kidney Cancer
For Condition: stage 4 renal cell cancer,recurrent renal cell cancer,stage 3 renal cell cancer
Status: No longer recruiting
Sponsor(s): Theradex ,
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 DHA-paclitaxel in treating patients who have locally advanced, metastatic, or unresectable kidney cancer.
Details: OBJECTIVES: I. Determine the tumor response rate, duration of response, and time to disease progression in patients with locally advanced, metastatic, or unresectable renal cell cancer treated with DHA-paclitaxel. II. Determine the overall survival of patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Assess the quality of life of patients treated with this drug. PROTOCOL OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses, and at completion of treatment. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed renal cell cancer Locally advanced OR Metastatic OR Unresectable - Measurable disease - No known or clinical evidence of CNS metastasis --Prior/Concurrent Therapy-- - Biologic therapy: At least 28 days since prior immunotherapy; No concurrent immunotherapy - Chemotherapy: No prior chemotherapy for advanced disease; No prior taxanes; At least 28 days since prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: At least 28 days since prior hormonal therapy; No concurrent hormonal therapy - Radiotherapy: At least 28 days since prior large-field radiotherapy; No concurrent radiotherapy - Surgery: At least 14 days since prior major surgery - Other: Concurrent bisphosphonates allowed if on stable dose for at least 30 days prior to study; No other concurrent anticancer therapy --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT or SGPT no greater than 2.5 times ULN - Renal: Creatinine no greater than 2.5 mg/dL - Cardiovascular: No uncontrolled ventricular arrhythmia; No myocardial infarction within the past 3 months; No superior vena cava syndrome - Neurologic: No peripheral neuropathy greater than grade 1; No uncontrolled major seizure disorder; No spinal cord compression - Other: No other prior malignancy except: Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR Cancer curatively treated with surgery alone that has not recurred for more than 5 years; No concurrent serious infection requiring parenteral therapy; No unstable or serious concurrent medical conditions; No psychiatric disorder that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 6 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RonaldBukowski, Study Chair, Theradex
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536-0093
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Arizona Oncology Associates
Tucson, Arizona, 85712-2254
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000068928; PROTARGA-P01-00-07,CCF-IRB-4046,THERADEX-P01-00-07
Study Start Date: April 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024388
Other Recurrent Renal Cell Cancer Studies:
1. Vaccine Therapy in Treating Patients With Kidney Cancer
2. Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Kidney Cancer or Malignant Melanoma
3. Interleukin-2, Vinblastine, and GM-CSF in Treating Patients With Metastatic Kidney Cancer
4. Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
5. Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer
Related Studies:
Other recurrent renal cell cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Chemotherapy in Treating Patients With Metastatic Kidney Cancer
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