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Home > "I" Clinical Trials Conditions > Irinotecan in Combination with Leucovorin and Fluorouracil to Treat Cancer  Irinotecan in Combination with Leucovorin and Fluorouracil to Treat Cancer
Irinotecan in Combination with Leucovorin and Fluorouracil to Treat Cancer
For Condition: Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will determine what dose of irinotecan can safely be given along with fluorouracil (5-FU) to adult cancer patients. Irinotecan and fluorouracil are both anti-cancer drugs that fight cancer cells in different ways. Giving both drugs together may work better against cancer than either one by itself. Leucovorin is a vitamin that enhances the effect of 5-FU. Patient 18 years of age and older with a solid tumor that does not respond to standard therapy (surgery, chemotherapy or radiation therapy) or for which standard therapy is not available may be eligible for this study. Also, patients with untreated cancer for whom this treatment is a reasonable first-line therapy are eligible. Candidates will be screened for the study over a period of several days to weeks with X-ray studies or magnetic resonance imaging (MRI), blood tests, including HIV screening, and a pregnancy test for women of childbearing age. Participants will have a plastic tube called a "central venous catheter" surgically placed in a large vein in the neck or under the collarbone, through which drug therapy will be given and blood samples collected. Irinotecan will be infused over 24 hours starting day 1. When the infusion is completed on day 2, leucovorin will be infused over 30 minutes, followed by a 48-hour infusion of 5-FU. This regimen will be repeated in 2 weeks (on days 15, 16 and 17) and then no drug will be given days 18 through 28. This completes one 28-day treatment cycle. A second cycle will begin on day 29. At the end of the second cycle, patients' response to treatment will be evaluated. Those whose tumor shrank or remained stable and who tolerated the drugs may receive additional cycles. Those whose tumor grew during treatment will come off the study. The dose of irinotecan will be gradually increased in succeeding groups of three to six patients if the previous dose was tolerated. When the highest tolerated dose is determined, additional patients will be given this dose, and the dose of 5-FU will be gradually increased in groups of patients. The dose of leucovorin will remain constant throughout the study. In addition to drug therapy, patients will have the following tests and procedures: - Blood samples will be taken before starting chemotherapy and over a 72-hour period after treatment begins to measure blood levels of irinotecan and 5-FU and to study proteins that might affect drug side effects. - Blood will be drawn weekly to check cell counts and at the start of each cycle to determine the effects of the drugs on liver and kidney function. - X-ray studies will be done about every 8 weeks to check disease progress. - Bone-marrow samples will be taken before chemotherapy starts and shortly before the first 5-FU infusion is completed. This procedure involves numbing the hip area and putting a needle into the bone near the hip to withdraw a teaspoonful of marrow. - A small sample of tumor tissue will be taken (biopsied) before beginning treatment to study proteins involved in how irinotecan and 5-FU will likely affect tumor growth. Only low-risk tumor biopsies will be done. Patients will keep a diary of drug side effects they experience. Patients who respond well to treatment will continue therapy without a fixed stopping point.
Details: The primary purpose of this protocol is to determine recommended doses of irinotecan given as a 24-hr IV infusion followed by a 30 min infusion of leucovorin and a 48-hr IV infusion of 5-FU every 2 weeks. 5-FU is an antimetabolite with activity in cancers arising in the gastrointestinal tract, breast, head and neck, and ovary. Irinotecan is a topoisomerase I-interacting agent with activity in cancers arising in the gastrointestinal tract, breast, lung and ovary. Preclinical studies suggest that administration of irinotecan six to 24 hr prior to 5-FU leads to synergistic cytotoxicity, and the antitumor effects are better than seen with either concurrent administration or the opposite sequence. Experimental data suggests that prolonged exposure to low concentrations of irinotecan is more effective than short exposures to higher concentrations, and is better tolerated in animal models. Our prior trial of irinotecan given as a 96-hour infusion weekly for 2 of 3 weeks was well tolerated, and was associated with a 6-fold higher molar ratio of the active metabolite, SN-38, to parent compound, compared to that seen with the typical 60-90 min infusions. A twice-monthly schedule of leucovorin-modulated 5-FU given as a 48-hr infusion is an active and well tolerated regimen. The starting dose for irinotecan, 70 mg/m(2) is 50% of the recommended single agent phase II dose when given as a 24-hr infusion every 2 weeks with oral UFT (a prodrug of 5-FU). The starting dose of 5-FU, 1000 mg/m(2), is 50% of the recommended dose when given with high-dose leucovorin as a 48-hr infusion every 2 weeks. Initially, the dose of irinotecan will be escalated in 25% increments with a fixed dose of 5-FU. Cohorts of 3 patients will be entered at each dose level until dose-limiting toxicity is seen. The dose of 5-FU will then be escalated in combination with irinotecan at one dose level below the MTD. Accrual will be expanded at the recommended doses of both irinotecan and 5-FU to allow pharmacokinetic and pharmacodynamic correlations at uniform doses. Treatment will be continued indefinitely until evidence of disease progression, provided the patient is tolerating therapy and wishes to continue.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Cancer patients who have failed standard therapy for their disease or for whom no such therapy is available are eligible, including patients with locally advanced, but non-resectable primary or recurrent solid tumors, or metastatic disease. Patients with metastatic cancer for whom this regimen represents a reasonable initial therapy, such as cancers arising the small bowel, colon or rectum, are eligible. Pathology will be reviewed to confirm the diagnosis of cancer. Objectively measurable disease is not required. Patients with surgically documented, but clinically undetectable recurrent or metastatic disease, will be eligible. Performance Status of 0-2. Prior Treatment: (The following criteria should be met): a) Greater than 4 weeks should have elapsed since prior chemotherapy or immunotherapy, & the patient should have recovered from the toxicities associated with such therapy. If prior nitrosoureas or mitomycin C have been given, at least 6 weeks should have elapsed. Prior therapy with irinotecan given as a short-infusion & prior therapy with 5-FU is allowed. b) Two or more weeks should have elapsed since any radiotherapy, & the patient should have recovered from the toxicity associated with such therapy. If prior strontium therapy has been given, however, at least eight weeks should have elapsed. c) If a recent surgical procedure has been performed, the patient should have recovered from the surgery prior to entering this trial. Patients should have an absolute granulocyte count greater than or equal to 2000/microliter & a platelet count greater than or equal to 100,000/microliter. Patients should have adequate hepatic function as indicated by a serum bilirubin less than or equal to 1.6 mg/dL & aspartate transaminase (AST, SGOT) levels less than or equal to 4 x upper limits of normal. All patients should have adequate renal function as indicated by a serum creatinine less than or equal to 1.6 mg/dL. The patient must willingly give signed informed consent. Age greater than or equal to 18 years of age. EXCLUSION CRITERIA: Patients with leukemia & lymphoma are not eligible. Pregnant women & nursing mothers are ineligible due to possible risk of adverse effects in the newborn. Eligible patients of reproductive potential should use adequate contraception. Serious concurrent medical illness which would jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safety. Patients with active infections requiring intravenous antibiotic therapy are not eligible until the infection has resolved. Patients who are HIV antibody positive are ineligible as this condition may jeopardize the ability of the patient to receive this cytotoxic chemotherapy program with reasonable safety. Patients with primary CNS malignancies & CNS metastatic disease are ineligible. Patients with known hypersensitivity to irinotecan or a history of marked intolerance to 5-FU are ineligible.
Total Enrollment: 40
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 010082; 01-C-0082
Study Start Date: February 3, 2001
Record last reviewed: January 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021515
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Irinotecan in Combination with Leucovorin and Fluorouracil to Treat Cancer
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