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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2012

Interventions

  • 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

Arms, Groups and Cohorts

  • 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)

Clinical Trial Outcome Measures

Primary 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
  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ottawa Hospital Research Institute
  • Collaborator
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean Maroun, MD, Principal Investigator, The Ottawa Hospital Cancer Centre

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