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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020488 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I & Pharmacologic Trial Of Sequential Irinotecan As A 24-Hour IV Infusion, Leucovorin, & Flurouracil As A 48-Hour IV Infusion In Adult Cancer Patients |
Study Start Date: | February 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of irinotecan and fluorouracil.
Patients receive irinotecan IV continuously over 24 hours on days 1 and 15 and leucovorin calcium IV over 30 minutes followed by fluorouracil IV continuously over 48 hours on days 2 and 16. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. Once the MTD of irinotecan has been determined, additional cohorts receive escalating doses of fluorouracil until the 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.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 20 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed advanced solid tumor that has failed standard therapy or for which no standard therapy exists
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
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: | Eva Szabo, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000068548, NCI-01-C-0082, MB-NAVY-00-02, MB-NAVY-B00-038 |
Study First Received: | July 11, 2001 |
Last Updated: | January 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00020488 |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Calcium, Dietary Fluorouracil Irinotecan Leucovorin Camptothecin |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Vitamins Micronutrients Antineoplastic Agents, Phytogenic |