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

NCT ID: NCT00819754

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2012-05-31

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.

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

IXO regimen + bevacizumab

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

irinotecan - Camptosar; capecitabine - Xeloda; Oxaliplatin - Eloxatin; bevacizumab - Avastin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

Ottawa Regional Cancer Foundation

UNKNOWN

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Maroun, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital Cancer Centre

Locations

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

0TT 03-03

Identifier Type: -

Identifier Source: org_study_id