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

Part of paid clinical trials in Macon, Georgia.

Sponsor
Accelerated Community Oncology Research Network
Study ID
NCT00779311
Phase
PHASE1
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • sorafenib — DRUG
    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.
  • bevacizumab — DRUG
    Bevacizumab will be administered as 5mg/kg IV on Day 1 of each treatment cycle.
  • mFOLFOX6 regimen — DRUG
    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.

Study Details

This research study is being performed at approximately 3 sites associated with Accelerated Community Oncology Research Network, Inc. (ACORN). Approximately 45 subjects will take part in this study. In this study, everyone will receive the same dose of mFOLFOX6 and Avastin. There will be five groups of subjects. Each group of subjects will receive a higher dose of Nexavar than the previous group. This will continue until a subject group has a major side effects from the dose they are given. This is so that the sponsor can determine the highest dose of Nexavar that can be used with mFOLFOX6 and AVastin (this is called the maximum tolerated dose or MTD).

Key Dates

First listed
Oct 24, 2008
Start date
Oct 31, 2008
Status verified
Oct 2011
Primary completion
Mar 31, 2011
Completion
Mar 31, 2011

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimenal
    All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle. Sorafenib will be administered daily throughout treatment beginning on day 1

Primary Outcome Measure

Determination of the Maximum Tolerated Dose (MTD) of Sorafenib When Given in Combination With mFOLFOX6 and Bevacizumab [ Time Frame: MTD was assessed during the first 2 cycles of treatment (i.e., the first 4 weeks of treatment since cycle length is 2 weeks) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Central Georgia Cancer CareMaconGeorgia31201-
Hematology Oncology Centers of the Northern RockiesBillingsMontana59101-
The West ClinicMemphisTennessee38120-

Find similar trials in Macon, GA

By research site
Central Georgia Cancer Care· Macon, GAHematology Oncology Centers of the Northern Rockies· Billings, MTThe West Clinic· Memphis, TN

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