XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer
C04.588.274.476.411.307
About this trial
This is an interventional treatment trial for C04.588.274.476.411.307 focused on measuring Colorectal neoplasm, Capecitabine (Xeloda), Oxaliplatin (Eloxatin), Advanced disease, Metastatic disease, First-line treatment, Phase II study
Eligibility 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
Sites / Locations
- Department of Oncology, Esbjerg Hospital
- Department of Oncology, Herlev University Hospital
- Department of Oncology, Herning Hospital
- Department of Oncology, Hillerød Hospital
- Department of Oncology, Næstved Hospital
- Department of Oncology, Roskilde Hospital
- Department of Oncology, Radiumhemmet
- Department of Oncology, Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
A
B
Standard XELOX
Chronomodulated XELOX