Clinical Trials Logo
  1. Home
  2. Metastatic Colorectal Cancer
  3. NCT00778830

Study Evaluating the Safety and Efficacy of FOLFIRI Plus Cetuximab or FOLFOX Plus Cetuximab as First-line Therapy in Subjects With KRAS Wild-type Metastatic Colorectal Cancer (APEC-Study) — APEC  

Metastatic Colorectal Cancer Clinical Trial

Official title:
An Asia Pacific Non-randomized, Open-label Phase II Study Evaluating the Safety and Efficacy of FOLFIRI Plus Cetuximab (Erbitux) or FOLFOX Plus Cetuximab as First-line Therapy in Subjects With KRAS Wild-type Metastatic Colorectal Cancer (APEC-Study)

Clinical Trial Summary

This is an open-label, non-randomized, multicenter Phase II study evaluating folinic acid + fluorouracil + irinotecan (FOLFIRI) plus cetuximab (Erbitux) or folinic acid + fluorouracil + oxaliplatin (FOLFOX) plus cetuximab as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.

Only subjects with k-ras oncogene (KRAS) wild-type tumors are eligible. Efficacy will be assessed every 8 weeks. Treatment will be continued until progressive disease or unacceptable adverse events occur. After the end of study treatment, information on further anticancer treatment and survival will be collected every 3 months.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00778830
Study type Interventional
Source Merck KGaA
Contact
Status Completed
Phase Phase 1/Phase 2
Start date February 2009
Completion date April 2014
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Withdrawn NCT05412706 - Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy Phase 2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