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Phase IIstudy of biweekly FOLFIRI+cetuximab treatment for unresectable KRAS-wild type colorectal cancer

ABSTRACT: Interventions: administration of cetuximab biweekly Primary outcome(s): Response rate Study Design: Single arm Non-randomized

DISEASE(S): Unresectable Colorectal Cancer

PROVIDER: 2626734 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase II trial of irinotecan with biweekly cetuximab in unresectable advanced and/or metastatic colorectal cancer, evaluation of the safety and efficacy based on EGFR positive and KRAS wild type.(i-BEX trial)

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Phase II study of biweekly cetuximab therapy for unresectable colorectal cancer

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Phase II trial of biweekly cetuximab and irinotecan as third-line therapy for pretreated KRAS exon 2 wild-type colorectal cancer.

Project description:Efficacy and safety of biweekly cetuximab plus irinotecan were evaluated to provide guidance for its use in Japan as third-line treatment for pretreated metastatic colorectal cancer (mCRC) patients harboring wild-type KRAS exon 2. Objective response rate (ORR) was used as primary endpoint based on an expected proportion of 0.23 with confidence width of 0.298 (95% CI, 0.105-0.403), which showed 35 to be the minimal participant number. Forty patients, refractory to first- and second-line chemotherapy containing irinotecan, oxaliplatin, and fluoropyrimidine, were enrolled. ORR and disease control rate were 25.0% (95% CI: 11.5-38.4) and 72.5% (95% CI: 56.8-86.4), respectively. Median progression-free survival (PFS), overall survival (OS), and number of courses were 5.70 months (95% CI: 2.7-7.9), 15.1 months (95% CI: 11.8-19.0), and 10.5 (range: 3.0-31.0), respectively. Grade 3 adverse events were skin toxicity (12.5%), diarrhea (10.0%), neutropenia (5.0%), febrile neutropenia (5.0%), nausea (5.0%), anorexia (5.0%), and fatigue (2.5%). Cmax mean was 723.2 μg/mL after first dose. High area under the curve (AUC)last variance was associated with t1/2 range of 131.2-1209.6 hours (median, 174.4 hours). Early tumor shrinkage (ETS) and median depth of response were 25.0% and 13.0%, respectively. Mutation frequencies in KRAS exon 3 or 4, NRAS, BRAF, and PIK3CA were 5.5%, 2.7%, 8.3%, and 5.5%, respectively. Multivariate Cox regression analysis assessed whether any gene mutations and ETS are predictors for PFS, and whether performance status, synchronous metastasis, and ETS are predictors for OS. Importantly, the data provide guidance for a biweekly cetuximab plus irinotecan regimen in mCRC patients.

| S-EPMC6113428 | biostudies-literature

Phase II study of FOLFIRI+biweekly cetuximab for KRAS wild type unresectable colorectal cancer.

Project description:Primary outcome(s): Response rate

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Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)

Project description:Interventions: Irinotecan plus S-1 (IRSI) with biweekly cetuximab combination therapy 1)Irinotecan 100 mg/m2 day1,15, 30 biweekly until PD 2)S-1 80mg [BSA<1.25m2] or 100mg [1.25m2<BSA<1.5m2] or 120mg [1.5m2<BSA]/body/day, day 1-14, q4weeks 3)Cetuximab 500mg/m2 day 1, 15, 29 biweekly until PD Primary outcome(s): Response rate Study Design: Single arm Non-randomized

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MicroRNA expression profiling identified miR-31-5p/3p as associated with time to progression in wild-type KRAS metastatic colorectal cancer treated with cetuximab but not panitumumab

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2016-05-05 | E-MTAB-3548 | biostudies-arrayexpress

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Project description:Interventions: biweekly cetuximab Primary outcome(s): Response rate Study Design: Single arm Non-randomized

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