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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045318 |
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.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: exatecan mesylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of DX-8951f (Exatecan Mesylate for Injection) in Patients With Renal Dysfunction |
Study Start Date: | May 2002 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Renal function as defined by the following parameters:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095 | |
United States, Texas | |
Brooke Army Medical Center | |
Fort Sam Houston, Texas, United States, 78234 | |
Cancer Therapy and Research Center | |
San Antonio, Texas, United States, 78229 | |
St. Luke's Lutheran Hospital | |
San Antonio, Texas, United States, 78229 | |
Veterans Affairs Medical Center - San Antonio (Murphy) | |
San Antonio, Texas, United States, 78284 |
Study Chair: | Carolyn Britten, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000256866, UCLA-0201008, DAIICHI-8951A-PRT026, NCI-G02-2103 |
Study First Received: | September 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00045318 |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
DX 8951 Camptothecin |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |