Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Hoffmann-La Roche
Pfizer
Sanofi
Ottawa Regional Cancer Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00819754
First received: January 8, 2009
Last updated: April 13, 2012
Last verified: July 2011
History of Changes
  Purpose

Triplets of irinotecan, oxaliplatin and infusional 5-FU/leucovorin are associated with high response rates and long survival as first-line treatment for 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.


Condition Intervention Phase
Metastatic Colorectal Cancer
 Drug: Irinotecan, Xeloda and Oxaliplatin (IXO) Regimen with Avastin (Bevacizumab)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Trial of Combination of Irinotecan, Xeloda and Oxaliplatin (IXO) Regimen With Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rates and duration of response [ Time Frame: every 2 cycles - 6 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
  • Qualitative and quantitative toxicity [ Time Frame: continuous ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 54
Study Start Date: November 2003
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
This is phase I/II safety and efficacy study. There is only one arm.
 Drug: Irinotecan, Xeloda and Oxaliplatin (IXO) Regimen with Avastin (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819754

Locations
Canada, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Hoffmann-La Roche
Pfizer
Sanofi
Ottawa Regional Cancer Foundation
Investigators
Principal Investigator: Jean Maroun, MD The Ottawa Hospital Cancer Centre
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00819754     History of Changes
Other Study ID Numbers: 0TT 03-03
Study First Received: January 8, 2009
Last Updated: April 13, 2012
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Irinotecan
Capecitabine
Bevacizumab
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013