XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer

November 4, 2020 updated by: Per Pfeiffer, Odense University Hospital

XELOX III. Capecitabine (Xeloda) in Combination With Oxaliplatin (Eloxatin) as First-line Treatment of Patients With Advanced or Metastatic Colorectal Cancer. A Randomized Phase II Study

XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes).

Bloodsamples will be collected and frozen and later examined for potential predictive factors

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Esbjerg, Denmark, 6700
        • Department of Oncology, Esbjerg Hospital
      • Herlev, Denmark, 2730
        • Department of Oncology, Herlev University Hospital
      • Herning, Denmark, 7400
        • Department of Oncology, Herning Hospital
      • Hillerød, Denmark, 3400
        • Department of Oncology, Hillerød Hospital
      • Næstved, Denmark, 4700
        • Department of Oncology, Næstved Hospital
      • Roskilde, Denmark, 4000
        • Department of Oncology, Roskilde Hospital
  • Sweden
      • Stockholm, Sweden, 100 26
        • Department of Oncology, Radiumhemmet
      • Uppsala, Sweden, 751 85
        • Department of Oncology, Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological proven adenocarcinoma of the colon or rectum
  • Measurable or non-measurable disease
  • Performance status 0-2
  • Adequate renal and hepatic functions
  • Adjuvant chemotherapy must have ended 180 days before inclusion
  • Written informed consent prior to randomization

Exclusion Criteria:

  • Prior treatment with Eloxatin or Xeloda
  • Peripheral neuropathy
  • Evidence of CNS metastasis
  • Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months)
  • Past history of malignant neoplasm within the past five years, except curatively treated non melanoma skin cancer
  • Administration of any other experimental drug under investigation within 2 weeks before randomisation
  • Pregnant or breast feeding women
  • Fertile patients must use adequate contraceptives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
Standard XELOX
Drug: Capecitabine (Xeloda)
Drug: Oxaliplatin (Eloxatin)
ACTIVE_COMPARATOR: B
Chronomodulated XELOX
Drug: Capecitabine (Xeloda)
Drug: Oxaliplatin (Eloxatin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)

Secondary Outcome Measures

Outcome Measure
Physical examination: before treatment (each 3 weeks)
Performance status: before treatment (each 3 weeks)
Haematology: before treatment (each 3 weeks)
Tumor biology: after 1st treatment, every 9th weeks herafter
Biochemistry: after every 3rd treatment (each 9th weeks)
Tumor assesment: after every 3rd treatment (each 9th weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Per Pfeiffer, MD, Department of Oncology, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2004

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 21, 2005

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XELOX III
  • KFE 03.17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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