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Study of Modified FOLFOX6 Plus or Minus Sorafenib in Stage IV Metastatic Colorectal Carcinoma (mCRC) Subjects

NCT00865709 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2014-12-11

Study results available
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Summary

To determine if sorafenib when added to chemotherapy will slow disease progression more than chemotherapy alone in patients previously untreated for metastatic colorectal cancer.

Conditions

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)

Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)

DRUG

Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)

Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-01-31
Completion
2012-02-29

Countries

  • United States
  • Belgium
  • Hungary
  • Italy
  • Poland
  • Romania
  • Russia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00865709 on ClinicalTrials.gov