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Phase I Trial of Sorafenib + FOLFIRI In Metastatic Colorectal Cancer

NCT00780169 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-05-13

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, the maximum tolerated dose and the recommended dose for phase II studies of a chemotherapy-combination of sorafenib, irinotecan, and 5-fluorouracil (5-FU)/folinic acid (FA) (FOLFIRI) as first-line treatment for metastatic colorectal cancer.

Conditions

Interventions

DRUG

sorafenib + FOLFIRI

escalating doses of sorafenib and irinotecan * sorafenib starting dose 400 mg/day * irinotecan starting dose 80 mg/m2 on day 1

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Jean A Maroun, MD · The Ottawa Hospital Regional Cancer Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-05-31
Completion
2012-12-31

Countries

  • Canada

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 NCT00780169 on ClinicalTrials.gov