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

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ClinicalTrials.gov Identifier: NCT00212615
Recruitment Status : Unknown
Verified October 2009 by Odense University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : October 19, 2009
Sponsor:
Information provided by:
Odense University Hospital

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 116 participants
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
Study Start Date : February 2004
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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)


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

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

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


Locations
Denmark
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
Sweden
Department of Oncology, Radiumhemmet
Stockholm, Sweden, 100 26
Department of Oncology, Uppsala University Hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Per Pfeiffer, MD Department of Oncology, Odense University Hospital

Publications:
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 Posted: September 21, 2005    Key Record Dates
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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents