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XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer
This study is ongoing, but not recruiting participants.
Study NCT00212615   Information provided by Odense University Hospital
First Received: September 13, 2005   Last Updated: October 16, 2009   History of Changes

September 13, 2005
October 16, 2009
February 2004
 
Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)
Same as current
Complete list of historical versions of study NCT00212615 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
 
XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer
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

 
Phase II, Phase III
Interventional
Treatment, Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety/Efficacy Study
C04.588.274.476.411.307
  • Drug: Oxaliplatin (Eloxatin)
  • Drug: Capecitabine (Xeloda)
 
Pfeiffer P, Hahn P, Jensen HA. Short-time infusion of oxaliplatin (Eloxatin) in combination with capecitabine (Xeloda) in patients with advanced colorectal cancer. Acta Oncol. 2003;42(8):832-6.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
116
October 2008
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Sweden
 
NCT00212615
 
XELOX III, KFE 03.17
Odense University Hospital
 
Principal Investigator: Per Pfeiffer, MD Department of Oncology, Odense University Hospital
Odense University Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP