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

Phase 1

Terminated

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: IXO regimen + bevacizumab

• Registration Number: NCT00819754
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Primary Completion: 2012-02
• Study Completion: 2012-05
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IXO regimen + bevacizumab	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada