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

Metastatic Colorectal Cancer Clinical Trial

— IXO+A  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00819754
• Other study ID #: 0TT 03-03
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: January 8, 2009
• Last updated: January 10, 2014
• Start date: November 2003
• Est. completion date: May 2012

Study information

• Verified date: January 2014
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Hoffmann-La Roche, Ottawa Regional Cancer Foundation, Pfizer, Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	Response rates and duration of response		every 2 cycles - 6 weeks	No
Secondary	Overall survival		continuous	Yes
Secondary	Qualitative and quantitative toxicity		continuous	Yes