- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01293942
IXO+A in mCRC With Liver-only Metastases
A Single-arm Phase II Downsizing Study of Irinotecan, Capecitabine and Oxaliplatin (IXO) and Bevacizumab as First-line Treatment to Assess Conversion to Resectability of Liver-only Metastases in Colorectal Cancer Patients With Initially Unresectable Metastases
The percentage of patients with defined unresectable metastatic disease who will benefit from a first-line treatment enabling secondary complete metastasectomy is unknown but limited. Definition of optimized treatment algorithms is difficult due to very inhomogeneous patient populations.
This open label, multicentre Phase II study primarily aims to assess the resection rate achievable in a selected patient population with initially unresectable metastatic disease limited to the liver only in order to evaluate feasibility, safety and efficacy with regards to secondary resection of hepatic lesions in these patients.
The trial aims to enrol only patients meeting defined criteria of unresectability with regards to their hepatic lesions and will exclude patients with extrahepatic lesions in order to examine the most appropriate, highly active treatment regimen for this group of unresectable patients with the highest probability of a successful secondary metastasectomy with curative intent. The trial will be conducted in highly specialized centres with a track record of successful interdisciplinary treatment approaches in the field of metastatic colorectal cancer to allow the precise assessment of the peri-operative safety parameters as well as an evaluation of the surgical treatment approaches.
The IXO regimen selected for this study has shown in a phase I/II study promising efficacy and a favourable safety profile. Bevacizumab has demonstrated a significant survival benefit in combination with chemotherapy in metastatic colorectal cancer. Therefore the study will allow evaluation of its potential benefit in combination with the two most active current chemotherapy regimens in the first-line and post-operative treatment setting.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital Cancer Center
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5T 2S8
- University Health Network
-
-
Quebec
-
Montreal, Quebec, Canada, H3A 1A1
- McGill University Health Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary colorectal cancer with unresectable metastatic lesion(s)
- At least one measurable lesion, confirmed by CT scan
- Male and female patients, aged ≥ 18 years
- ECOG performance score of 0 or 1 (within 1 week of study treatment start)
- Written informed consent
- Adequate general condition, cardiopulmonary functions and performance status
- Liver metastases no initially foreseen R0 resection of all hepatic lesions, but deemed potentially resectable after response to downsizing therapy
Exclusion Criteria:
- Extrahepatic metastatic disease
- Prior systemic or local treatment for metastatic disease, prior therapy with a biologic agent, prior adjuvant or neo-adjuvant chemotherapy, prior radiotherapy to the liver, other concurrent chemotherapy
- Inadequate bone marrow, liver, renal function, uncontrolled hypertension
- Pregnancy or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IXO+A
IXO regimen with Avastin
|
IXO plus bevacizumab regimen is given every 3 weeks (Q3W), in the following order: Bevacizumab (A): 7.5 mg/kg via IV infusion, day 1 Oxaliplatin (O): 100 mg/m2 via 2-hour IV infusion, day 1 Irinotecan (I): 160 mg/m2 via 1-hour IV infusion, day 1 Capecitabine (X): 950 mg/m2 twice daily PO, days 2 - 15
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
conversion to resectability during downsizing therapy with IXO+A patients with initially unresectable liver-only metastases associated with colorectal cancer
Time Frame: after 8 IXO+A cycles
|
after 8 IXO+A cycles
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrence-free survival (RFS)
Time Frame: Every 2 cycles
|
Every 2 cycles
|
Progression-free survival (PFS)
Time Frame: Every 2 cycles
|
Every 2 cycles
|
Time to response (TTR)
Time Frame: Every 2 cycles
|
Every 2 cycles
|
Overall survival (OS)
Time Frame: Every 2 cycles
|
Every 2 cycles
|
Pathological complete response (pCR) rate
Time Frame: assessed post-operatory
|
assessed post-operatory
|
Overall response rate (ORR)
Time Frame: Every 2 cycles
|
Every 2 cycles
|
Number of participants with Adverse Events as a measure of Safety and Tolerability
Time Frame: Every 3 weeks
|
Every 3 weeks
|
Surgical safety (frequency of surgical complications)
Time Frame: assessed post-operatory
|
assessed post-operatory
|
Pathological changes in the non-tumoural liver following therapy with IXO+A
Time Frame: assessed post-operatory
|
assessed post-operatory
|
R0, R1, R2 resection rate after up to 8 cycles of downsizing therapy with IXO+A
Time Frame: assessed post-operatory
|
assessed post-operatory
|
Collaborators and Investigators
Investigators
- Study Chair: Jean Maroun, MD, The Ottawa Hospital Cancer Centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Colorectal Neoplasms
- Neoplasm Metastasis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Topoisomerase I Inhibitors
- Capecitabine
- Oxaliplatin
- Bevacizumab
- Irinotecan
Other Study ID Numbers
- OTT 10-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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