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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Odense University Hospital.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: September 21, 2005
Last Update Posted: October 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Odense University Hospital

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 Intervention Phase
C04.588.274.476.411.307 Drug: Oxaliplatin (Eloxatin) Drug: Capecitabine (Xeloda) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Odense University Hospital:

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

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 116
Study Start Date: February 2004
Estimated Study Completion Date: October 2008

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212615

Department of Oncology, Esbjerg Hospital
Esbjerg, Denmark, 6700
Department of Oncology, Herlev University Hospital
Herlev, Denmark, 2730
Department of Oncology, Herning Hospital
Herning, Denmark, 7400
Department of Oncology, Hilleroed Hospital
Hilleroed, Denmark, 3400
Department of Oncology, Naestved Hospital
Naestved, Denmark, 4700
Department of Oncology, Roskilde Hospital
Roskilde, Denmark, 4000
Department of Oncology, Radiumhemmet
Stockholm, Sweden, 100 26
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00212615     History of Changes
Other Study ID Numbers: XELOX III
KFE 03.17
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: October 19, 2009
Last Verified: October 2009

Keywords provided by Odense University Hospital:
Colorectal neoplasm
Capecitabine (Xeloda)
Oxaliplatin (Eloxatin)
Advanced disease
Metastatic disease
First-line treatment
Phase II study

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents