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Study to Evaluate the Effects of Sorafenib if Combined With Chemotherapy (FOLFOX6 or FOLFIRI) in the Second-Line Treatment of Colorectal Cancer

NCT00889343 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2013-03-04

No results posted yet for this study

Summary

The purpose of this study is to determine whether sorafenib in combination with chemotherapy has a positive effect on time to progression of the tumor or death for the treatment of large bowel cancer that has already progressed during a first chemotherapy.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

Sorafenib

2x200 mg filmcoated tablets BID on day 2-12 of a 14-days cycle, oral

DRUG

Placebo

2 filmcoated tablets BID, day 2-12 of a 14-days cycle, oral

DRUG

Oxaliplatin or Irinotecan

Oxaliplatin 100 mg/m2 intravenous infusion on day 1 of 14-days cycle, Irinotecan 180 mg/m2 intravenous infusion on day 1 of 14-days cycle

DRUG

Leucovorin

400 mg/m2 intravenous infusion on day 1 of a 14-days cycle

DRUG

5-Fluorouracil

400 mg/m2 intravenous bolus infusion on day 1, 2400 mg/m2 46 hour intravenous infusion on day 1 to 2 of a 14-days cycle

Sponsors & Collaborators

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Thomas Höhler, Prof. Dr. med.

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
2011-11-30
Completion
2012-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT00889343 on ClinicalTrials.gov