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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00042861 |
RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Combining UCN-01 with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining UCN-01, fluorouracil, and leucovorin in treating patients who have metastatic or unresectable solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: 7-hydroxystaurosporine Drug: fluorouracil Drug: leucovorin calcium |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Pharmacologic Trial Of Infusional UCN-01 Given With A Weekly Schedule Of 5-Fluorouracil And Leucovorin |
Study Start Date: | August 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of fluorouracil (5-FU).
Patients receive leucovorin calcium (CF) IV over 2 hours and 5-FU IV (at the midpoint of CF administration) on day 1, followed by UCN-01 IV over 36-72 hours, on weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 5-FU until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The recommended phase II dose (RPIID) is defined as the dose preceding the MTD. At least 6 additional patients are treated at the RPIID.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 16 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Jean L. Grem, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000069478, NCI-NAVY-01-04, NCI-5535, NCI-02-C-0222 |
Study First Received: | August 5, 2002 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00042861 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Antimetabolites Vitamin B Complex Immunologic Factors Leucovorin Trace Elements 7-hydroxystaurosporine Folinic Acid |
Immunosuppressive Agents Protein Kinase Inhibitors Calcium, Dietary Fluorouracil Vitamins Staurosporine Micronutrients |
Antimetabolites Vitamin B Complex Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Leucovorin Enzyme Inhibitors |
7-hydroxystaurosporine Protein Kinase Inhibitors Immunosuppressive Agents Pharmacologic Actions Vitamins Fluorouracil Therapeutic Uses Staurosporine Micronutrients |