Status:
UNKNOWN
Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies
Lead Sponsor:
Aronex Pharmaceuticals
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and capecitabine in subjects with unres...
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00081536
Last Update
June 24 2005
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