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OpenTrials
Completed

NCT Number: NCT00212615

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

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

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Key information

Conditions

C04.588.274.476.411.307 Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Oncology, Esbjerg Hospital, Esbjerg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxaliplatin (Eloxatin)

Drug

Capecitabine (Xeloda)

Drug

Primary outcomes

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

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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