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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by Odense University Hospital. Recruitment status was Active, not recruiting

First Received on September 13, 2005. Last Updated on October 16, 2009 History of Changes

Sponsor:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00212615

Purpose

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 II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: 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:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Oxaliplatin Capecitabine

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00212615 History of Changes
Other Study ID Numbers:	XELOX III, KFE 03.17
Study First Received:	September 13, 2005
Last Updated:	October 16, 2009
Health Authority:	Denmark: Central Scientific Ethical Committee

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
Oxaliplatin

Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012