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

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ClinicalTrials.gov Identifier: NCT00819754
Recruitment Status : Terminated
First Posted : January 9, 2009
Last Update Posted : January 14, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: IXO regimen + bevacizumab Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2003
Primary Completion Date : February 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Response rates and duration of response [ Time Frame: every 2 cycles - 6 weeks ]
  2. Overall survival [ Time Frame: continuous ]
  3. Qualitative and quantitative toxicity [ Time Frame: continuous ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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).
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00819754     History of Changes
Other Study ID Numbers: 0TT 03-03
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014

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
Bevacizumab
Oxaliplatin
Irinotecan
Capecitabine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites