IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer

NCT ID: NCT01237665

Last Updated: 2012-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2017-12-31

Brief Summary

This is a prospective open label single-arm, single-institution phase II clinical trial to test the efficacy of neoadjuvant treatment with IXO (Irinotecan, Capecitabine [Xeloda], Oxaliplatin) followed by chemoradiotherapy and resection in patients with resectable non-metastatic primary rectal cancer of stage cT3-T4 N0-N2.

Conditions

Rectal Cancer

Keywords

locally resectable advanced adenocarcinoma of the rectum

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IXO regimen

single-group

Group Type: EXPERIMENTAL

IXO regimen

Intervention Type: DRUG

IXO regimen is administered as following: irinotecan 160 mg/m2 i.v. (over 60-90 minutes) with oxaliplatin 100 mg/m2 i.v. (over 120 minutes) on day 1, followed by capecitabine 950 mg/m2 PO, b.i.d. on days 2-15, every 3 weeks.

Each cycle of IXO lasts 21 days, with the subsequent cycle to start on day 22.

Interventions

IXO regimen

IXO regimen is administered as following: irinotecan 160 mg/m2 i.v. (over 60-90 minutes) with oxaliplatin 100 mg/m2 i.v. (over 120 minutes) on day 1, followed by capecitabine 950 mg/m2 PO, b.i.d. on days 2-15, every 3 weeks.

Each cycle of IXO lasts 21 days, with the subsequent cycle to start on day 22.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

General

• Pathologically confirmed rectal adenocarcinoma
• T3 or T4 or N1 (node ≥1 cm on short axis) adenocarcinoma of the rectum.
• ECOG performance status equal or less than 1
• Male and female patients, aged ≥ 18 years and ≤ 80 years
• Written informed consent
• Adequate haematological, liver, renal function

Resectability

• Patients categorized as having resectable locally advanced cancer
• Favorable general condition

Exclusion Criteria

Resectability

• Diagnosis of metastatic disease
• Clear indication of involvement of pelvic wall(s), on imaging.
• Peritoneal carcinomatosis, portal vein occlusion, ascites, non-regional lymph nodes
• Histology other than adenocarcinoma
• Obstructed rectal carcinoma without defunctionalizing colostomy

Prior treatment

• Previously undergone treatment for this disease
• Prior chemotherapy for colorectal cancer
• Prior chemotherapy for other malignancies in past 12 months
• Prior radiotherapy other than skin cancer
• Concomitant use of St John's Wort
• Treatment with any other investigational agent
• Current use of full-dose of warfarin for therapeutic

Other conditions

• Confirmed or suspected brain metastases
• History or evidence of CNS disease
• Past or current history of other malignancies
• Clinically significant cardiovascular disease
• Evidence of bleeding diathesis or coagulopathy
• Known hypersensitivity to any of the study drugs
• Serious, non-healing wound, ulcer or bone fracture
• Major surgical procedure or significant traumatic injury within 28 days prior to treatment
• Disease or condition that contraindicates the use of an investigational drug
• Life expectancy less than 5 years
• Inability or unwillingness to comply with the protocol
• Neuropathy ≥ Gr.2
• History of ulcerative colitis or Crohn's disease
• Pelvic abscess or perforated pelvic carcinoma

Pregnancy / Contraception

• Pregnancy or lactation
• Positive serum pregnancy test within 7 days of starting study treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Regional Cancer Foundation

UNKNOWN

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Derek Jonker, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital Cancer Centre

Locations

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

OTT 09-02

Identifier Type: -

Identifier Source: org_study_id