Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

July 31, 2005

Study Completion Date

October 31, 2007

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan

DRUG

FOLFOX 6

"FOLFOX 6:~* Oxaliplatin 100 mg/m² d1 concurrent with~* Leucovorin 400 mg/m², followed by~* Bolus 5FU 400 mg/m² , followed by~* Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:"

DRUG

FOLFIRI

"FOLFIRI:~* Irinotecan 180 mg/m² day 1 concurrent with~* Leucovorin 400 mg/m² followed by~* Bolus 5FU 400 mg/m², followed by~* Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks"

Trial Locations (27)

1000

Institute of Oncology, Ljubljana

1090

Univ. Klinik für Innere Medizin I, Vienna

1135

National Medical Center, Budapest

1504

"University Hospital Queen Joanna", Sofia

1754

SBALO National Oncology Center, Sofia

2720

Hospital Amadora Sintra, Servico de Oncologia, Amadora

8200

Csolnoky Ferenc County Hospital, Veszprém

8700

LKH Leoben, Abt. für Innere Medizin, Leoben

12808

Charles University Prague, Dep. of Oncology, Prague

39700

Markusovsy Hospital, Szomathely

62500

Univ. Hospital Brno, Dept. Of Clinical Oncology, Brno

71000

Institute of Oncology, Sarajevo

78000

Hospital de Beja, Beja

83310

National Cancer Institute, Bratislava

400015

Institutul Oncologic Cluj, Cluj-Napoca

Unknown

University Hospital for Tumors, Zagreb

University Hospital Rebro, Zagreb

Bank of Cyprus Oncology Center, Nicosia

Hadassah Medical Center, Jerusalem

Souraski Medical Center, Tel Aviv

Hospital San Teotóno -, Viseu

Institutul Oncologic Bucuresti, Bucharest

Ankara Hacettepe University, Oncology Unit, Ankara

Gazi University Medical Faculty, Ankara

9 Eyul University Medical Faculty, Dep of Oncology, Izmir

8000-386

Hospital Distrital de Faro, Faro

4000-377

Hospital Geral de Sto. António, Porto

All Listed Sponsors
lead

Central European Cooperative Oncology Group

OTHER

NCT00286130 - Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter