FOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma

PHASE2/PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 31, 2008

Primary Completion Date

March 31, 2009

Study Completion Date

March 31, 2009

Conditions
Colorectal CarcinomaLiver Metastases
Interventions
DEVICE

SIR-Spheres microspheres

SIR-Spheres yttrium-90 microspheres

DRUG

FOLFOX6 cycles 1-3

Oxaliplatin 60 mg/m2, IV infusion, q 2 weeks Leucovorin 200 mg/m2, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks

DRUG

FOLFOX6 cycles 4 onwards

Oxaliplatin 85 mg/m2 given, IV infusion, q 2 weeks Leucovorin 200 mg/m2 given, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks

DRUG

Bevacizumab cycles 3 onwards

Bevacizumab 10 mg/m2, IV infusion, q 2 weeks commencing with the third cycle of chemotherapy

Trial Locations (3)

28208

Carolinas Medical Center, Charlotte

48073

William Beaumont Hospital, Royal Oak

99204

Sacred Heart Medical Center, Spokane

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sirtex Medical

INDUSTRY