A Phase II Trial Assessing the Efficacy and Toxicity of Capecitabine and Oxaliplatin in the Treatment of Colorectal Cancer.
- 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
- 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
- Medical or psychiatric condition that comprise the patient's ability to take informed
- 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.