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

Odense University Hospital (Other)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Oxaliplatin (Eloxatin)
  • Drug: Capecitabine (Xeloda)
Phase 2/Phase 3

Study Design

Study Type:
Actual Enrollment :
116 participants
Intervention Model:
Factorial Assignment
None (Open Label)
Primary Purpose:
Official Title:
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
Actual Study Start Date :
Feb 1, 2004
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A

Standard XELOX

Drug: Oxaliplatin (Eloxatin)

Drug: Capecitabine (Xeloda)

Active Comparator: B

Chronomodulated XELOX

Drug: Oxaliplatin (Eloxatin)

Drug: Capecitabine (Xeloda)

Outcome Measures

Primary Outcome Measures

  1. Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event) []

Secondary Outcome Measures

  1. Physical examination: before treatment (each 3 weeks) []

  2. Performance status: before treatment (each 3 weeks) []

  3. Haematology: before treatment (each 3 weeks) []

  4. Tumor biology: after 1st treatment, every 9th weeks herafter []

  5. Biochemistry: after every 3rd treatment (each 9th weeks) []

  6. Tumor assesment: after every 3rd treatment (each 9th weeks) []

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 Department of Oncology, Esbjerg Hospital Esbjerg Denmark 6700
2 Department of Oncology, Herlev University Hospital Herlev Denmark 2730
3 Department of Oncology, Herning Hospital Herning Denmark 7400
4 Department of Oncology, Hillerød Hospital Hillerød Denmark 3400
5 Department of Oncology, Næstved Hospital Næstved Denmark 4700
6 Department of Oncology, Roskilde Hospital Roskilde Denmark 4000
7 Department of Oncology, Radiumhemmet Stockholm Sweden 100 26
8 Department of Oncology, Uppsala University Hospital Uppsala Sweden 751 85

Sponsors and Collaborators

  • Odense University Hospital


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

Study Documents (Full-Text)

None provided.

More Information


Responsible Party:
Per Pfeiffer, Professor, M.D., Odense University Hospital
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • KFE 03.17
First Posted:
Sep 21, 2005
Last Update Posted:
Nov 6, 2020
Last Verified:
Nov 1, 2020
Keywords provided by Per Pfeiffer, Professor, M.D., Odense University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 6, 2020