A Phase I/II Study of Aroplatin and Capecitabine in Subjects With Unresectable Local Recurrence or Distant Metastases of Colorectal Cancer Refractory to 5-FU/Leucovorin and Irinotecan
Data Collection
Colonic Diseases+8
+ Digestive System Diseases
+ Digestive System Neoplasms
Treatment Study
Summary
Phase I Primary Objective: * Determine the MTD of Aroplatin/capecitabine subjects with unresectable local recurrence or distant metastases of colorectal cancer refractory to 5-FU/LV and irinotecan. Phase II Primary Objective: * Evaluate the response proportion and duration with Aroplatin/capecitabine therapy. Phase II Secondary Objective: * Evaluate the frequency of adverse events.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.105 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.