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modifiedFOLFOX6 + Cetuximab oxaliplatin 85 mg/m2 on day 1, 15 q d29 for 6 cycles folinic acid (FA) 400 mg/m2 on days 1 and 15 and q d29 for 6 cycles fluorouracil (5-FU) 400 mg/m2 bolus day 1 + 2400 mg/m2 46-hour infusion on days 1, 2 and 15, 16 and q d29 for 6 cycles or until unacceptable toxicity Cetuximab will be administered as a 120- minute intravenous infusion at 500 mg/m2 on day 1 then 500 mg/m2 bi-weekly

FOLFIRI + Cetuximab irinotecan 180 mg/m² on day 1, 15 q d29 for 6 cycles folinic acid (FA)400 mg/m2 on days 1 and 15 and q d29 for 6 cycles fluorouracil (5-FU) 400 mg/m2 bolus + 2400 mg/m2 46-hour infusion on days 1, 2 and 15, 16 and q d29 for 6 cycles or until unacceptable toxicity Cetuximab will be administered as a 120- minute intravenous infusion at 500 mg/m2 on day 1 then 500 mg/m2 bi-weekly

FOLFIRI + Cetuximab

modifiedFOLFOX6 + Cetuximab

Thomas Winder, MD

This pilot study is being mounted to assess whether treatment assignment by ERCC-1 gene expression status suggests better clinical results from historical experience in metastatic colorectal cancer (mCRC). In wild type KRAS mCRC patients treated with either FOLFOX or FOLFIRI in combination with cetuximab the median response rate is approximately 60-65%. Biomarker directed treatment in this study may demonstrate that patients with low ERCC-1 treated with FOLFOX and cetuximab, and those with high ERCC-1 treated with FOLFIRI and cetuximab, will improve response rate to 70-75%. KRAS wild type patients will be treated with 6 cycles of one of the following regimens chosen for optimization based on patient characteristics (primary treatment phase). Patients with ERCC-1 \< 1.7 relative gene expression of ERCC-1 over ß-actin (ERCC-1 low) will be assigned to treatment with mFOLFOX6 in combination with Cetuximab. Patients with ERCC-1 gene expression \> 1.7 relative gene expression of ERCC-1 over over ß-actin (ERCC-1 high) will be assigned to treatment with FOLFIRI in combination with Cetuximab.

Biomarker Directed Treatment in Metastatic Colorectal Cancer

Pilot Study: Biomarker Directed Treatment in Metastatic Colorectal Cancer

Treatment response according to Response Evaluation Criteria In Solid Tumors \[RECIST\]

Description of group differences between ERCC-1 low and ERCC-1 high patients with respect to response rate, PFS and OS

Description of group differences between ERCC-1 low and ERCC-1 high patients with respect to KRAS status

Merck Sharp & Dohme LLC

Arbeitsgemeinschaft medikamentoese Tumortherapie

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Biomarker Directed Treatment in Metastatic Colorectal Cancer	NCT01703390	Metastatic Colo...	FOLFIRI + Cetux... modifiedFOLFOX6...	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie
Biomarker Directed Treatment in Metastatic Colorectal Cancer	NCT01703390	Metastatic Colo...	FOLFIRI + Cetux... modifiedFOLFOX6...	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie

Spots Global Cancer Trial Database for modifiedfolfox6 + cetuximab