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Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084877 |
RATIONALE: Drugs used in chemotherapy such as irinotecan work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for their growth and may help irinotecan kill more tumor cells by making them more sensitive to the drug.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan and 3-AP in treating patients with metastatic or unresectable solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: irinotecan hydrochloride Drug: triapine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Triapine® in Combination With Irinotecan in Refractory Tumors |
Estimated Enrollment: | 36 |
Study Start Date: | March 2004 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a dose-escalation study.
Patients receive irinotecan IV over 1 hour on day 1 and 3-AP (Triapine^®) IV over 2 hours on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan and 3-AP (Triapine^®) 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. Once the MTD is determined, 6 additional patients are treated at that dose.
Patients are followed until disease progression.
PROJECTED ACCRUAL: Approximately 12-36 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
No known brain or meningeal metastases unless the patient meets all of the following criteria:
Baseline screening test for UGT1A1 required
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Principal Investigator: | Kyle D. Holen, MD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000366936, WCCC-CO-03903, NCI-6264 |
Study First Received: | June 10, 2004 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00084877 |
Health Authority: | United States: Food and Drug Administration |
unspecified adult solid tumor, protocol specific |
Irinotecan Camptothecin |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |