A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer (IXO+A)
Primary Purpose
Metastatic Colorectal Cancer
Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
IXO regimen + bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer
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
Sites / Locations
- The Ottawa Hospital Cancer Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IXO regimen + bevacizumab
Arm Description
This is phase I/II safety and efficacy study. There is only one arm of Irinotecan, Xeloda and Oxaliplatin (IXO) regimen with Avastin (bevacizumab)
Outcomes
Primary Outcome 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
Phase II: Using the RD established in phase I, assess efficacy of the IXO with bevacizumab combination as measured by progression-free survival
Secondary Outcome Measures
Response rates and duration of response
Overall survival
Qualitative and quantitative toxicity
Full Information
NCT ID
NCT00819754
First Posted
January 8, 2009
Last Updated
January 10, 2014
Sponsor
Ottawa Hospital Research Institute
Collaborators
Hoffmann-La Roche, Pfizer, Sanofi, Ottawa Regional Cancer Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00819754
Brief Title
A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Study Start Date
November 2003 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Hoffmann-La Roche, Pfizer, Sanofi, Ottawa Regional Cancer Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IXO regimen + bevacizumab
Arm Type
Experimental
Arm Description
This is phase I/II safety and efficacy study. There is only one arm of Irinotecan, Xeloda and Oxaliplatin (IXO) regimen with Avastin (bevacizumab)
Intervention Type
Drug
Intervention Name(s)
IXO regimen + bevacizumab
Other Intervention Name(s)
irinotecan - Camptosar, capecitabine - Xeloda, Oxaliplatin - Eloxatin, bevacizumab - Avastin
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
Response rates and duration of response
Time Frame
every 2 cycles - 6 weeks
Title
Overall survival
Time Frame
continuous
Title
Qualitative and quantitative toxicity
Time Frame
continuous
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Maroun, MD
Organizational Affiliation
The Ottawa Hospital Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer
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