IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer (IXOr)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ottawa Regional Cancer Foundation
Sanofi
Hoffmann-La Roche
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01237665
First received: August 25, 2010
Last updated: October 12, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Drug: IXO regimen
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 Phase II Trial of Neoadjuvant IXO Regimen (Irinotecan, Capecitabine [Xeloda], Oxaliplatin) Followed by Combined Modality Capecitabine and Radiation for Locally Resectable Advanced Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Pathological complete response (pCR) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    To test the efficacy of neoadjuvant treatment with IXO followed by chemoradiotherapy and surgical resection, evaluated as histological therapy-induced tumour regression, assessed by the rate of pathological complete response (pCR) at the primary tumor site (pT0)


Secondary Outcome Measures:
  • Objective Response [ Time Frame: 12 weeks and 18 weeks ] [ Designated as safety issue: No ]
    Objective Response by MRI - post IXO and post RCT

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: every 3 weeks during neoadjuvant chemotherapy; before CRT; 3rd week of CRT; 2 days, 3 weeks and 6 weeks post CRT; pre-op; 2 days and 4 weeks post-op ] [ Designated as safety issue: Yes ]
    Toxicity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.3.0 and drug safety

  • Recurrence [ Time Frame: q6 months ] [ Designated as safety issue: No ]
    Rates of local and distant disease recurrence

  • RFS, PFS, TTR [ Time Frame: q6 months ] [ Designated as safety issue: No ]
    Recurrence free survival (RFS), progression free survival (PFS), time to recurrence (TTR)

  • Quality of life [ Time Frame: enrolment, 12 weeks, 18 weeks, 26 weeks ] [ Designated as safety issue: No ]
    Quality of life (QoL) as assessed by the EORTC QLQ-C30 scale

  • Surgical morbidity and mortality [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    post-operative

  • Rate of post-operative sphincter preservation [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    post-operative

  • OS [ Time Frame: q6 months first 2 years and annually thereafter ] [ Designated as safety issue: No ]
    overall survival (OS)


Estimated Enrollment: 15
Study Start Date: September 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IXO regimen
single-group
Drug: 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.


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237665

Locations
Canada, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Ottawa Regional Cancer Foundation
Sanofi
Hoffmann-La Roche
Investigators
Principal Investigator: Derek Jonker, MD The Ottawa Hospital Cancer Centre
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01237665     History of Changes
Other Study ID Numbers: OTT 09-02
Study First Received: August 25, 2010
Last Updated: October 12, 2012
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
locally resectable advanced adenocarcinoma of the rectum

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Irinotecan
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on August 01, 2014