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First-line Therapy of Stage IV Colorectal Cancer

NCT00784446 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2013-01-07

No results posted yet for this study

Summary

Assessment of safety and toxicity, definition of the dose limiting toxicity (DLT) of the combination therapy consisting of Capecitabine, Oxaliplatin, Bevacizumab and Imatinib.

Conditions

  • Stage IV Colorectal Cancer

Interventions

DRUG

Oxaliplatin, Capecitabine, Bevacizumab, Imatinib

Dose level I: Bevacizumab day 1: 7,5 mg/kg body weight Oxaliplatin day 1: 100 mg/m2 Capecitabine days 1-14 bid: 800 mg/m2 Imatinib days 1-21: 300 mg Repeat on day 22. Dose level II: Bevacizumab day 1: 7,5 mg/kg body weight Oxaliplatin day 1: 130 mg/m2 Capecitabine days 1-14 bid: 1000 mg/m2 Imatinib days 1-21: 300 mg Repeat on day 22.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • University of Cologne

    lead OTHER

Principal Investigators

  • Ulrich Hacker, PD Dr. · University Cologne

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-08-31
Completion
2012-12-31

Countries

  • Germany

Study Locations

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Entities

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 NCT00784446 on ClinicalTrials.gov