Status:
COMPLETED
XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer
Lead Sponsor:
Odense University Hospital
Conditions:
C04.588.274.476.411.307
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00212615
Start Date
February 1 2004
End Date
October 1 2008
Last Update
November 6 2020
Active Locations (8)
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1
Department of Oncology, Esbjerg Hospital
Esbjerg, Denmark, 6700
2
Department of Oncology, Herlev University Hospital
Herlev, Denmark, 2730
3
Department of Oncology, Herning Hospital
Herning, Denmark, 7400
4
Department of Oncology, Hillerød Hospital
Hillerød, Denmark, 3400