A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer (IXO+A)

January 10, 2014 updated by: Ottawa Hospital Research Institute

A Phase I/II Clinical Trial of Combination of Irinotecan, Xeloda and Oxaliplatin (IXO) Regimen With Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer

Triplets of irinotecan, oxaliplatin and infusional 5-fluorouracil(FU)/leucovorin (LV) are associated with high response rates and long survival as first-line treatment for metastatic colorectal cancer (mCRC). The oral fluoropyrimidine, capecitabine, is better tolerated and shows better response rates than 5-FU/LV in metastatic colorectal cancer. A phase I dose-escalation study established dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II doses (RPIID) of irinotecan, oxaliplatin and capecitabine. This phase I /II study is to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), phase II recommended dose (RD) of IXO and bevacizumab combination and safety at the RD in an expanded cohort.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically documented adenocarcinoma of the colon or rectum.
  • Advanced and/or metastatic disease, incurable with standard therapy.
  • Unresectable advanced and/or metastatic unidimensionally measurable disease (RECIST scale).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Age: over 18 years.
  • Adequate haematological, renal and hepatic functions
  • Patient consent must be obtained according to local REB requirements.
  • Patients must be accessible for treatment and follow up.

Exclusion Criteria:

  • Previous or concurrent malignancies
  • Pregnant or lactating women. Women of childbearing potential must have had a negative pregnancy test within 7 days prior to registration.
  • Concurrent treatment with other experimental drugs or anticancer therapy.
  • Previous chemotherapy for advanced and/or metastatic disease.
  • Previous adjuvant therapy with irinotecan or oxaliplatin.
  • Previous full dose curative pelvic radiation therapy.
  • Patients with documented brain metastases.
  • Serious illness or medical condition.
  • Gilbert's disease
  • Use of enzyme inducing anticonvulsants such as phenytoin, phenobarbital and carbamazepine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IXO regimen + bevacizumab
This is phase I/II safety and efficacy study. There is only one arm of Irinotecan, Xeloda and Oxaliplatin (IXO) regimen with Avastin (bevacizumab)
Drug: IXO regimen + bevacizumab

Phase I study - identifies the safety of IXO with bevacizumab and recommended phase II dose

Phase II study - assesses efficacy and safety of IXO with bevacizumab

Other Names:
  • irinotecan - Camptosar
  • capecitabine - Xeloda
  • Oxaliplatin - Eloxatin
  • bevacizumab - Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase I: Assess the MTD and RD for phase II of IXO and bevacizumab combination given every 3 weeks in 1st line patients with mCRC
Time Frame: 3-week cycle, continuous monitoring of AE
3-week cycle, continuous monitoring of AE
Phase II: Using the RD established in phase I, assess efficacy of the IXO with bevacizumab combination as measured by progression-free survival
Time Frame: 3-week cycle, continuous monitoring of AE
3-week cycle, continuous monitoring of AE

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: continuous
continuous
Response rates and duration of response
Time Frame: every 2 cycles - 6 weeks
every 2 cycles - 6 weeks
Qualitative and quantitative toxicity
Time Frame: continuous
continuous

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

Sanofi
Pfizer
Hoffmann-La Roche
Ottawa Regional Cancer Foundation

Investigators

  • Principal Investigator: Jean Maroun, MD, The Ottawa Hospital Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 9, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0TT 03-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Colorectal Cancer

Clinical Trials on IXO regimen + bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe