Phase II Trial Assessing Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer

Inclusion criteria

• Age >18
• Histologically proven colorectal adenocarcinoma, requiring therapy as defined by one of the four treatment subgroups
• No previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix.
• Unidimensional measurable disease as assessed by CT. (Unless adjuvant therapy only)
• Adequate bone marrow function; Hb >10g/dl, platelets >100 x109/l, WBC >3x109/l, Neut >1.5x109/l.
• Adequate liver function: Serum Bilirubin <1.5 x upper limit of institutional normal
• Adequate renal function, calculated Creatinine Clearance >50mls/min
• No concurrent uncontrolled medical conditions
• WHO performance status 0,1 or 2
• Adequate contraceptive precautions, if appropriate
• Informed written consent
• Negative pregnancy test in women of child bearing age
• Life expectancy > 3 months

Exclusion criteria

• Medical or psychiatric condition that comprise the patient's ability to take informed consent.
• Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months.
• Patients with any significant symptoms or history of peripheral neuropathy.