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.