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

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00819754

Acronym

IXO+A

Enrollment

Registered

2009-01-09

Start date

2003-11-30

Completion date

2012-05-31

Last updated

2014-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

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.

Interventions

DRUGIXO 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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	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	3-week cycle, continuous monitoring of AE

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026