Overview

This trial is active, not recruiting.

Condition c04.588.274.476.411.307
Treatments oxaliplatin (eloxatin), capecitabine (xeloda)
Phase phase 2/phase 3
Sponsor Odense University Hospital
Start date February 2004
End date October 2008
Trial size 116 participants
Trial identifier NCT00212615, KFE 03.17, XELOX III

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)
time frame:

Secondary Outcomes

Measure
Physical examination: before treatment (each 3 weeks)
time frame:
Performance status: before treatment (each 3 weeks)
time frame:
Haematology: before treatment (each 3 weeks)
time frame:
Tumor biology: after 1st treatment, every 9th weeks herafter
time frame:
Biochemistry: after every 3rd treatment (each 9th weeks)
time frame:
Tumor assesment: after every 3rd treatment (each 9th weeks)
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Per Pfeiffer, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by Odense University Hospital.