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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 determine the effectiveness of two different regimens of combination chemotherapy in treating patients who have metastatic or unresectable solid tumors.
OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan, fluorouracil, and leucovorin calcium (Saltz regimen vs Mayo regimen) plus oxaliplatin (arm I vs arm II) in patients with metastatic or unresectable solid tumors. II. Determine the effect of irinotecan on the disposition of oxaliplatin in these patients. III. Assess the development of peripheral neuropathy in these patients on the Mayo regimen. IV. Determine the activity of these regimens in patients with metastatic solid tumors.
OUTLINE: This is a dose escalation study. Patients are entered to one of two treatment arms: Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22, followed by oxaliplatin IV over 2 hours on days 1 and 15. Courses repeat every 6 weeks. Arm II (Mayo regimen): Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1, followed by leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every 3 weeks. Cohorts of 3-6 patients receive escalating doses of fluorouracil (one of two treatment doses for arm II), and one of two treatment doses of irinotecan and oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for 3 months.
PROJECTED ACCRUAL: Up to 60 patients will be accrued for this study within 8-14 months.
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin
Mayo Clinic Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:02-0400
RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. ...
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 and giving the drugs in different combi...
This phase II trial studies how well combination chemotherapy, gemcitabine hydrochloride, and radiation therapy before surgery works in treating patients with borderline resectable pancrea...
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells...
RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stoppin...
Survival with nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in per-protocol and non-per-protocol populations of NAPOLI-1: Expanded analysis of a global phase 3 trial.
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The NAPOLI-1 study (NCT01494506) reported that liposomal irinotecan plus 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) improved overall survival vs 5-FU/LV with manageable toxicity in patients with ...
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The active metabolite of FOLIC ACID. Leucovorin is used principally as its calcium salt as an antidote to folic acid antagonists which block the conversion of folic acid to folinic acid.
A naphthalene derivative and CALCIMIMETIC AGENT that increases the sensitivity of PARATHYROID GLAND calcium-sensing receptors to serum calcium. This action reduces parathyroid hormone secretion and decreases serum calcium in the treatment of PARATHYROID DISEASES.
A phenylethylamine derivative that acts as a calcium antagonist showing hemodynamic effects in patients with acute myocardial infarction.
A folate analog consisting of the pharmacologically active isomer of LEUCOVORIN.
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