IXO+A in mCRC With Liver-only Metastases

NCT01293942 | Withdrawn Phase 2 DMC

• 1 other identifier: OTT 10-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Metastatic Colorectal Cancer

Keywords

unresectable liver-only metastases in colorectal cancer

Outcome Measures

Primary Outcomes (1)

• conversion to resectability during downsizing therapy with IXO+A patients with initially unresectable liver-only metastases associated with colorectal cancer

  after 8 IXO+A cycles

Secondary Outcomes (10)

• Recurrence-free survival (RFS)

  Every 2 cycles

• Progression-free survival (PFS)

  Every 2 cycles

• Time to response (TTR)

  Every 2 cycles

• Overall survival (OS)

  Every 2 cycles

• Pathological complete response (pCR) rate

  assessed post-operatory

Study Arms (1)

IXO+A

EXPERIMENTAL

IXO regimen with Avastin

Drug: irinotecan, capecitabine, oxaliplatin (IXO) and bevacizumab

Interventions

irinotecan, capecitabine, oxaliplatin (IXO) and bevacizumab DRUG

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

IXO+A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Hoffmann-La Roche: collaborator
• Sanofi: collaborator

Study Sites (4)

The Ottawa Hospital Cancer Center

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; Capecitabine; Oxaliplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jean Maroun, MD

  The Ottawa Hospital Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 11, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

CA (4)