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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)

ABSTRACT: 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

DISEASE(S): Colorectal Cancer

PROVIDER: 2617953 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A multicenter phase II study of FOLFIRI as first-line chemotherapy for metastatic colorectal cancer with reduced starting dose of irinotecan in patients with homozygous for UGT1A1(FLIGHT1)

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

Biomarker analysis of neoadjuvant Doxorubicin/Cyclophosphamide followed by Ixabepilone or Paclitaxel in early-stage breast cancer

2013-01-01 | GSE41998 | GEO

Biomarker analysis of neoadjuvant Doxorubicin/Cyclophosphamide followed by Ixabepilone or Paclitaxel in early-stage breast cancer

Project description:A randomized, open-label, multicenter, phase II trial (NCT00455533) enrolled previously untreated women with histologically-confirmed primary invasive breast adenocarcinoma (T2–3, N0–3, M0, tumor size ≥2.0 cm), regardless of hormone receptor or HER2 expression status. Patients received sequential neoadjuvant therapy starting with 4 cycles of AC (doxorubicin 60 mg/m2 intravenously and cyclophosphamide 600 mg/m2 intravenously) given every 3 weeks, followed by 1:1 randomization to either ixabepilone (40 mg/m2 3-hour infusion) every 3 weeks for 4 cycles, or paclitaxel (80 mg/m2 1-hour infusion) weekly for 12 weeks. Fresh tumor biopsies at screening were a mandatory prerequisite for study entry for biomarker analyses. Gene expression profiling was performed by Affymetrix GeneChip to determine if pre-specified gene models could distinguish between the clinical activity of two microtubule stabilizing agents, ixabepilone and paclitaxel. Three core needle tumor tissue biopsies were obtained from all subjects before neoadjuvant therapy with AC and immediately combined in RNAlater® solution for subsequent RNA extraction, cRNA labeling and gene expression profiling. Pre-specified gene models were tested for their capacity to distinguish pathologic complete response rates between the AC followed by ixabepilone versus the AC followed by paclitaxel treatment regimens. All samples were collected prior to treatment. All subject received cyclophosphamide/doxorubicin (AC) prior to randomization to either Ixabepilone or Paclitaxel.

2013-01-01 | E-GEOD-41998 | biostudies-arrayexpress

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

Project description: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

| 2620216 | ecrin-mdr-crc

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

Methotrexate Clearance GWAS

Project description:<p>We estimated the plasma clearance of methotrexate from 1279 acute lymphoblastic leukemia (ALL) patients treated on the Children Oncology Group 9904 and 9905 trials (<a href="http://clinicaltrials.gov/show/NCT00005585">http://clinicaltrials.gov/show/NCT00005585</a> and <a href="http://clinicaltrials.gov/show/NCT00005596)">http://clinicaltrials.gov/show/NCT00005596</a>). Patients received either a 24-hour infusion of a 1 g/m2 dose or 4-hour infusion of a 2 g/m2 dose). Methotrexate clearance was lower in older children (p=7 x 10-7), females (p=2.7 x 10-4), and patients who received a delayed intensification phase (p=0.0022). In a genome-wide analysis, methotrexate clearance was associated with polymorphisms in the SLCO1B1 gene (p=2.1 x 10-11), which encodes for an organic anion transporter. This replicates findings using different schedules of high-dose methotrexate in ALL patients treated on St. Jude protocols. A combined meta-analysis yields a p-value of 5.7 x 10-19 for the association of methotrexate clearance with SLCO1B1 SNP rs4149056 (Trevino et al, PMID 19901119 and Ramsey et al, PMID 23233662). This data set includes the dependent variable of methotrexate clearance and all of the SNP data available from arrays.</p>

| phs000637 | dbGaP

Phase I Clinical Trial of ES-285

Project description:Phase I Safety, Pharmacokinetic and Pharmacogenomic Trial of ES-285, a Novel Marine Cytotoxic Agent Administered as an Infusion over 24 h Every 21 Days in Patients with Solid Tumors Purpose: A dose-escalation, phase I study evaluated the safety, pharmacokinetics, pharmacogenomics and efficacy of ES-285, a novel agent isolated from a marine mollusc, in adult cancer patients. Experimental design: Patients received a 24-hour i.v. infusion of ES-285 once every 3 weeks until disease progression or unacceptable toxicity. The starting dose was 4mg/m2. Dose escalation proceeded according to the worst toxicity observed in the previous cohort. Results: 28 patients were treated with 72 courses of ES-285 across 8 dose levels. No doselimiting toxicities (DLTs) were seen between 4mg/m2 and 128mg/m2. Two out of 4 patients treated at 256mg/m2 had dose-limiting reversible grade 3 transaminitis; one patient at 256mg/m2 also had transient grade 3 central neurotoxicity. One of 3 patients subsequently treated at 200mg/m2 died following drug-related central neurotoxicity. Pharmacokinetic studies indicated dose-proportionality with high volume of distribution (median Vss at 256mg/m2 was 2389L, range 1615-4051L) and long elimination half life (median t1/2 at 256mg/m2 was 29h, range 21-32h). The 3 patients with DLT had the highest drug exposure. Pharmacogenomic studies of paired surrogate tissue samples identified changes in gene expression following treatment that correlated with increasing dose. Pre-treatment 59- and 49-gene sets were identified in blood and skin respectively, that may predict DLT. Disease stabilisation for 6 to 18 weeks was recorded in 9 patients. Conclusion: Using this schedule, 128 mg/m2 was considered safe and feasible. At this dose, pharmacologically relevant concentrations of drug were safely achieved with pharmacogenomic studies indicating changes in the expression of genes of potential biological relevance. Keywords: dose response

2009-04-01 | GSE12062 | GEO

Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer: EGFR positive and KRAS wild type

Project description:Interventions: FOLFIRI (CPT-11, 5-FU bolus, 5-FU infusional, l-LV)+ Erbitux Cetuximab 400 mg/m2(day1) Cetuximab 250 mg/m2/week, (except day 1) CPT-11 100 or 150 mg/m2/bi-week l-LV 200 mg/m2/bi-week 5-FU/bolus 400 mg/m2/bi-week 5-FU/infusional2,400 mg/m2/bi-week (day 1-3) Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2617576 | ecrin-mdr-crc

PhaseII study of Combination FOLFIRI with Cetuximab in patients with advanced/metastatic colorectal cancer previously received oxaliplatin-based chemoterapy.

Project description:Interventions: FOLFIRI (CPT-11, 5-FU bolus, 5-FU infusional, l-LV)+ Cetuximab 1) Cetuximab : 500 mg/m2/bi-week 2) CPT-11 : 100 or 150 mg/m2/bi-week 3) l-LV : 200 mg/m2/bi-week 4) 5-FU/bolus : 400 mg/m2/bi-week 5) 5-FU/infusional : 2,400 mg/m2/bi-week (day 1-3) Primary outcome(s): Response rate Study Design: Single arm Non-randomized

| 2622791 | ecrin-mdr-crc

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

Project description:Interventions: Intravenous adminstration of CPT-11 100 mg/m2 on Days 1, 8, and 15, every 4 weeks Primary outcome(s): 1)Tumor response rate 2)Genotype-phenotype association (CYP3A4,CES1,2, UGT1A1, ABCG2, ABCB1, and ABCC1,2 vs toxicity), mutation -phenotype association (TOP1A, ABCG2 vs tumor response), and expression-phenotype association (TOP1A, ABCG2 vs tumor response) Study Design: Single arm Non-randomized

| 2609520 | ecrin-mdr-crc

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