IXO+A in mCRC With Liver-only Metastases
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Colorectal Cancer |
Drug: irinotecan, capecitabine, oxaliplatin (IXO) and bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- 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 ] [ Designated as safety issue: No ]
- Recurrence-free survival (RFS) [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
- Progression-free survival (PFS) [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
- Time to response (TTR) [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
- Overall survival (OS) [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
- Pathological complete response (pCR) rate [ Time Frame: assessed post-operatory ] [ Designated as safety issue: No ]
- Overall response rate (ORR) [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
- Number of participants with Adverse Events as a measure of Safety and Tolerability [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]
- Surgical safety (frequency of surgical complications) [ Time Frame: assessed post-operatory ] [ Designated as safety issue: Yes ]
- Pathological changes in the non-tumoural liver following therapy with IXO+A [ Time Frame: assessed post-operatory ] [ Designated as safety issue: Yes ]
- R0, R1, R2 resection rate after up to 8 cycles of downsizing therapy with IXO+A [ Time Frame: assessed post-operatory ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IXO+A
single-group
|
Drug: irinotecan, capecitabine, oxaliplatin (IXO) and bevacizumab
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Ontario | |
| The Ottawa Hospital Cancer Center | Not yet recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Jean Maroun, MD 613-737-7700 ext 70185 jmaroun@ottawahospital.on.ca | |
| University Health Network | Not yet recruiting |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Contact: Steven Gallinger, MD steven.gallinger@uhn.on.ca | |
| Sunnybrook Health Sciences Centre | Not yet recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Scott Berry, MD scott.berry@sunnybrook.ca | |
| Canada, Quebec | |
| McGill University Health Centre | Not yet recruiting |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Contact: Peter Metrakos, MD (514) 843-1600 peter.metrakos@muhc.mcgill.ca | |
| Study Chair: | Jean Maroun, MD | The Ottawa Hospital Cancer Centre |
More Information
No publications provided
| Responsible Party: | Jean Maroun, The Ottawa Hospital Cancer Centre |
| ClinicalTrials.gov Identifier: | NCT01293942 History of Changes |
| Other Study ID Numbers: | OTT 10-01 |
| Study First Received: | February 8, 2011 |
| Last Updated: | February 9, 2011 |
| Health Authority: | Canada: Health Canada Canada: Ethics Review Committee |
Keywords provided by Ottawa Hospital Research Institute:
|
unresectable liver-only metastases in colorectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes Oxaliplatin |
Irinotecan Capecitabine Bevacizumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 23, 2013