Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies

Inclusion Criteria

• •Histologically confirmed colorectal cancer: unresectable local recurrence or distant metastases;
• •Measurable disease (RECIST criteria);
• •Refractory to 5-FU / leucovorin and irinotecan as described below;
• •No prior therapy with oxaliplatin, any other platinum or capecitabine;
• •ECOG score 0-2 (Karnofsky 100-70%);
• •Life expectancy of greater then or equal to 5 months;
• •Adequate hematopoietic, liver and renal function;
• •Women of child-bearing potential have to practice adequate contraception;
• •Signed written informed consent;
• •Subjects must be willing to be followed during the course of treatment/observation and follow-up.
• •Refractory metastatic colorectal cancer
• •The following subjects are regarded refractory to treatment:
• •Those with progression while receiving 5-FU/LV/irinotecan;
• •Those with progression on irinotecan after prior 5-FU/LV treatment;
• •Progression within six months of adjuvant 5-FU/LV/irinotecan;
• •Progression within six months of adjuvant 5-FU/LV followed by progression on irinotecan
• •Subjects must have received at least one or more commonly used 5-FU/leucovorin and irinotecan regimens. Prior adjuvant therapy is allowed including 5-FU/leucovorin or other fluoropyrimidines except capecitabine and irinotecan.