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Trial record 57 of 318 for:    colon cancer | ( Map: Canada )

IXO+A in mCRC With Liver-only Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01293942
Recruitment Status : Withdrawn
First Posted : February 11, 2011
Last Update Posted : June 5, 2013
Hoffmann-La Roche
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:

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 or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: irinotecan, capecitabine, oxaliplatin (IXO) and bevacizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IXO+A
IXO regimen with Avastin
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Recurrence-free survival (RFS) [ Time Frame: Every 2 cycles ]
  2. Progression-free survival (PFS) [ Time Frame: Every 2 cycles ]
  3. Time to response (TTR) [ Time Frame: Every 2 cycles ]
  4. Overall survival (OS) [ Time Frame: Every 2 cycles ]
  5. Pathological complete response (pCR) rate [ Time Frame: assessed post-operatory ]
  6. Overall response rate (ORR) [ Time Frame: Every 2 cycles ]
  7. Number of participants with Adverse Events as a measure of Safety and Tolerability [ Time Frame: Every 3 weeks ]
  8. Surgical safety (frequency of surgical complications) [ Time Frame: assessed post-operatory ]
  9. Pathological changes in the non-tumoural liver following therapy with IXO+A [ Time Frame: assessed post-operatory ]
  10. R0, R1, R2 resection rate after up to 8 cycles of downsizing therapy with IXO+A [ Time Frame: assessed post-operatory ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01293942

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Canada, Ontario
The Ottawa Hospital Cancer Center
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Ottawa Hospital Research Institute
Hoffmann-La Roche
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Study Chair: Jean Maroun, MD The Ottawa Hospital Cancer Centre

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Responsible Party: Ottawa Hospital Research Institute Identifier: NCT01293942     History of Changes
Other Study ID Numbers: OTT 10-01
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013
Keywords provided by Ottawa Hospital Research Institute:
unresectable liver-only metastases in colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors