A Phase I Trial Evaluating mFOLFOX6 and Avastin With Nexavar as First-Line Treatment for Metastatic Colorectal Cancer

PHASE1TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

sorafenib

Sorafenib will be administered daily starting day 1 at 200mg QOD at Dose Level 1; 200mg/day at Dose Level 2; 200mg BID (5 days on/ 2 days off) at Dose Level 3; 200mg BID at Dose Level 4; and 400mg BID at Dose Level 5.

DRUG

bevacizumab

Bevacizumab will be administered as 5mg/kg IV on Day 1 of each treatment cycle.

DRUG

mFOLFOX6 regimen

The mFOLFOX6 regimen will be administered on Day 1 of each treatment cycle. This regimen consists of oxaliplatin 85 mg/m2 IV given over 2 hours, leucovorin 400 mg/m2 IV given over 2 hours, and fluorouracil 400 mg/m2 IV bolus, followed by fluorouracil 1200 mg/m2 per day for 2 days continuous infusion.

Trial Locations (3)

31201

Central Georgia Cancer Care, Macon

38120

The West Clinic, Memphis

59101

Hematology Oncology Centers of the Northern Rockies, Billings

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Accelerated Community Oncology Research Network

OTHER