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. Exclusion criteria: Previously diagnosed brain metastases if symptomatic and requiring active therapy; Other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin; Concurrent chemotherapy or immunotherapy; Prior therapy for colorectal cancer within one month of admission to the present study; Primary or secondary immunodeficiency or use of corticosteroids or other immunosuppressive medication; Any serious concomitant medical or mental illness requiring intense therapy and interfering with participation in this study; Women must not be pregnant or breast-feeding; No participation in any clinical trial involving investigational drugs within 1 month from enrollment into the present study.