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Keep this study
Lead
Aronex Pharmaceuticals
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies
