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A feasibility study of Irinotecan (CPT-11) by groups of Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphisms in patients with metastatic colorectal cancer.

ABSTRACT: Interventions: Patients receive FOLFIRI with bevacizumab fixed 5mg/kg. (Treatment will be continued unless the disease progression, unacceptable toxicity, or consent withdrawal.) Definision of UGT1A1 polymorphisms groups: The homozygous group is patient with homozygous genotype of UGT1A1*28/*28 or UGT1A1*6/*6, with combined heterozygous genotypes of UGT1A1*28 and UGT1A1*6. The heterozygous group is patient with heterozygous genotype of either UGT1A1*28 or UGT1A1*6. The wild group is patients with no UGT1A1*28 and UGT1A1*6 mutation. CPT-11 dosage is wild and heterozygous:CPT-11 150mg/m2 homozygous:CPT-11 100mg/m2 Primary outcome(s): 1)incidence of adverse events 2)frequency of severe toxicity Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2620216 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A genotype directed dose-finding study of Irinotecan (CPT-11) by groups of Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphisms in patients with advanced metastatic colorectal cancer and gastric cancer.

Project description:Interventions: Administraion of CPT-11 is twice for 4 weeks on days 1 and 15. CPT-11 is reconstituted in >=250 mL of normal saline or 5% dextrose in water and infuse 90min on day 1 for pharmacokinetics, and 90min over on day15. CPT-11 adjusted dosage is determined from 50,75,100,125 or 150mg/sqm in the heterozygous group and the homozygous group by continual reassessment method. CPT-11 dosage is fixed at 150mg/sqm in the wild group.Definision of UGT1A1 polymorphisms groups: The homozygous group is patient with homozygous genotype of UGT1A1*28/*28 or UGT1A1*6/*6, with combined heterozygous genotypes of UGT1A1*28 and UGT1A1*6. The heterozygous group is patient with heterozygous genotype of either UGT1A1*28 or UGT1A1*6. The wild group is patients with no UGT1A1*28 and UGT1A1*6 mutation. Primary outcome(s): Maximum tolerated dose for the heterozygous group and the homozygous group, respectively. Incidence rate of dose limiting toxicities for the wild group. Study Design: Single arm Non-randomized

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Study to Evaluate the Efficacy and Safety of FOLFIRI-AD in Patients With Metastatic Colorectal Cancer UGT1A Genotype 1

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Study the relationship between UGT1A1, MTHFR gene polymorphism and colorectal cancer chemotherapy sensitivity

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Individual Dosage Selection of Irinotecan (CPT-11) Based on UGT1A1 Genotype in Metastatic Colorectal Cancer Patients

Project description:The purpose of this study is to investigate the influence of dose selection of CPT-11 on toxicity, response and pharmacokinetics according to UGT1A1 genotype in colorectal cancer patients.

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Phase 2 trial of FOLFIRI plus ziv-aflibercept in patients with colorectal cancer previously treated with oxaliplatin, fluoropyrimidins, bevacizumab, and trifluridine/tipiracil

Project description:Interventions: FOLFIRI plus ziv-aflibercept (Day 1) Ziv-aflibercept, 4 mg/kg, intravenously (IV) over 60 min (Day 1) Irinotecan, 150 mg/m2, IV over 90 min (Day 1) Leucovorin (l-LV), 200 mg/m2, IV over 120 min (Day 1) 5-FU, 400 mg/m2, bolus (Day 1-3) 5-FU, 2400 mg/m2, continuous infusion over 46 h Repeat the above every two weeks The dose of irinotecan can be reduced to 120 mg/m2 if patients are homozygous for UGT1A1*28 or UGT1A1*6, or heterozygous for both UGT1A1*28 and UGT1A1*6.;C480833,C533178;FOLFIRI, ziv-aflibercept Primary outcome(s): progression free survival Study Design: single arm study, open(masking not used), historical control, single assignment, treatment purpose

| 2614963 | ecrin-mdr-crc

Pharmacogenomic Study for Individual Response to CPT-11 in Colorectal Cancer Patients (Step 2)

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Project description:Interventions: On Day 1, patients treated with FOLFIRI therapy received a 2-hour intravenous infusion of CPT-11 (150 mg/m2) combined with 1-LV (200 mg/m2), followed by a rapid intravenous infusion of 5-FU (400 mg/m2), and then a 46-hour continuous infusion of 5-FU (2,400 mg/m2). This regimen comprised one course of therapy and was repeated once every 2 weeks. Cycles of treatment will be continued for this study until disease progression (PD) occurs. Patients will undergo UGT1A1 genotyping before starting to receive the protocol treatment. As recommended in the US prescribing information for Camptosar;, the starting dose of CPT-11 will be reduced to 100 mg/m2 in patients who are homozygous for the *28 allelic variant of UGT1A1 (further reduced to 75 mg/m2 in such patients aged 76-80 years). No dose adjustments will be made in patients who undergo UGT1A1 genotyping after starting to receive the protocol treatment. Primary outcome(s): (1)response rate (2)incidence and severity of adverse events Study Design: Single arm Non-randomized

| 2617865 | ecrin-mdr-crc

A multicenter phaseII study of FOLFIRI as FOLFOX refractory second-line chemotherapy for metastatic colorectal cancer with reduced starting dose of irinotecan in patients with honozygous for UGT1A1: (FLIGHT2)

Project description:Interventions: On Day 1, patients treated with FOLFIRI therapy received a 2-hour intravenous infusion of CPT-11 (150 mg/m2) combined with 1-LV (200 mg/m2), followed by a rapid intravenous infusion of 5-FU (400 mg/m2), and then a 46-hour continuous infusion of 5-FU (2,400 mg/m2). This regimen comprised one course of therapy and was repeated once every 2 weeks. Cycles of treatment will be continued for this study until disease progression (PD) occurs. Patients will undergo UGT1A1 genotyping before starting to receive the protocol treatment. As recommended in the US prescribing information for Camptosar;, the starting dose of CPT-11 will be reduced to 100 mg/m2 in patients who are homozygous for the *28 allelic variant of UGT1A1 (further reduced to 75 mg/m2 in such patients aged 76-80 years). No dose adjustments will be made in patients who undergo UGT1A1 genotyping after starting to receive the protocol treatment. Primary outcome(s): (1) response rate (2) incidence and severity of adverse events Study Design: Single arm Non-randomized

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