C04.588.274.476.411.307
Conditions
Keywords
Colorectal neoplasm, Capecitabine (Xeloda), Oxaliplatin (Eloxatin), Advanced disease, Metastatic disease, First-line treatment, Phase II study
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 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
Interventions
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event) | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemistry: after every 3rd treatment (each 9th weeks) | — |
| Tumor assesment: after every 3rd treatment (each 9th weeks) | — |
| Tumor biology: after 1st treatment, every 9th weeks herafter | — |
| Performance status: before treatment (each 3 weeks) | — |
| Haematology: before treatment (each 3 weeks) | — |
| Physical examination: before treatment (each 3 weeks) | — |
Countries
Denmark, Sweden
Outcome results
None listed