Biomarker Directed Treatment in Metastatic Colorectal Cancer

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01703390
Study type	Interventional
Source	Arbeitsgemeinschaft medikamentoese Tumortherapie
Contact
Status	Completed
Phase	Phase 2
Start date	December 4, 2012
Completion date	July 3, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01228734` - A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients	Phase 3
Completed	`NCT05178745` - A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
Completed	`NCT01591421` - P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Metastatic/Advanced RAS-Wild Type Colorectal Cancer.	Phase 1/Phase 2
Withdrawn	`NCT05412706` - Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy	Phase 2
Withdrawn	`NCT04430985` - FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer	Phase 2
Withdrawn	`NCT03182894` - Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer	Phase 1/Phase 2
Recruiting	`NCT05725200` - Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer	Phase 2
Terminated	`NCT03176264` - PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer	Phase 1
Completed	`NCT04866290` - HepaSphere™ Microspheres Prospective Registry
Not yet recruiting	`NCT06425133` - Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers	Phase 2
Not yet recruiting	`NCT05531045` - 18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
Withdrawn	`NCT03982173` - Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors	Phase 2
Completed	`NCT02906059` - Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer	Phase 1
Active, not recruiting	`NCT02575378` - Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer	Phase 4
Withdrawn	`NCT02535988` - Abscopal Effect for Metastatic Colorectal Cancer	Phase 2
Recruiting	`NCT02848807` - Chemotherapy-related Toxicity, Nutritional Status and Quality of Life	N/A
Active, not recruiting	`NCT02077868` - Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment	Phase 3
Completed	`NCT02414009` - Study to Compare CAPTEM vs FOLFIRI as Second Line Treatment in Advanced, Colorectal Cancer Patients	Phase 2
Active, not recruiting	`NCT01949194` - Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers	Phase 2
Withdrawn	`NCT01915472` - A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer	Phase 2