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Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction Clinical research trials and Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction. Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction clinical trial. Subjects frequently get the best healthcare possible for their Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction  Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction
Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
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 I trial to study the effectiveness of exatecan mesylate in treating patients who have advanced solid tumors and kidney dysfunction.
Details: OBJECTIVES: - Determine the maximum tolerated dose of exatecan mesylate in patients with advanced solid tumors and varying degrees of renal dysfunction. - Determine the dose-limiting and non-dose-limiting toxic effects of this drug in these patients. - Determine the effects of renal dysfunction on the plasma pharmacokinetics and pharmacodynamics of this drug in these patients. - Establish a model for dosing this drug in patients with impaired renal function. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to severity of renal dysfunction (normal vs mild vs moderate vs severe). Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients in each renal dysfunction stratum receive escalating doses of exatecan mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients in the normal renal function stratum do not undergo dose escalation. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 45 patients (6 normal, 9 mild, 12 moderate, and 18 severe renal dysfunction) will be accrued for this study within 1.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed advanced solid tumor refractory to standard therapy or for which no standard therapy exists - Renal function as defined by the following parameters: - Normal (creatinine clearance (CrCl) greater than 80 mL/min) - Mild dysfunction (CrCl 50-80 mL/min) - Moderate dysfunction (CrCl 30-50 mL/min) - Severe dysfunction (CrCl less than 30 mL/min) - End-stage renal disease (requiring dialysis) - No symptomatic or active brain metastases (e.g., edema or progression on CT scan or MRI) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin at least 9.0 g/dL Hepatic - Bilirubin normal - AST or ALT no greater than 2 times upper limit of normal - Albumin at least 2.8 g/dL Renal - See Disease Characteristics Cardiovascular - No active congestive heart failure - No uncontrolled angina - No myocardial infarction within the past 6 months Other - No concurrent serious infection - No other life-threatening illness - No overt psychosis or mental disability or other incompetency that would preclude informed consent - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent anticancer biologic therapy Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered - No prior exatecan mesylate - No other concurrent anticancer chemotherapy Endocrine therapy - No concurrent anticancer hormonal therapy - Concurrent megestrol for appetite stimulation allowed Radiotherapy - At least 4 weeks since prior radiotherapy and recovered - No concurrent anticancer radiotherapy Surgery - At least 4 weeks since prior major surgery and recovered - No concurrent anticancer surgery Other - At least 4 weeks since prior investigational drugs including analgesics or antiemetics - At least 1 week since prior grapefruit juice - No other concurrent anticancer therapy - No other investigational drugs during and for 4 weeks after study - No concurrent grapefruit juice - No other concurrent anticancer cytotoxic therapy - Concurrent chronic hemodialysis or ambulatory peritoneal dialysis allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CarolynBritten, Study Chair, Division of Hematology/Oncology
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Cancer Therapy and Research Center
San Antonio, Texas, 78229
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095
United States
St. Luke's Lutheran Hospital
San Antonio, Texas, 78229
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
United States
Additional Information:
Study ID Numbers: CDR0000256866; UCLA-0201008,DAIICHI-8951A-PRT026,NCI-G02-2103
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045318
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors
2. Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
3. UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
4. Temozolomide plus PEG-Interferon alfa-2B in Treating Patients With Advanced Solid Tumors
5. Buspirone in Reducing Shortness of Breath in Patients With Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction
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