Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies
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
1 other identifier
interventional
105
0 countries
N/A
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 unresectable, local recurrence or distant metastases of colorectal cancer refractory to 5-FU/leucovorin and irinotecan. In Phase II, the primary objective is to evaluate the response proportion and duration with Aroplatin/capecitabine therapy. Secondary objectives are to evaluate frequency and severity of adverse events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2004
CompletedFirst Posted
Study publicly available on registry
April 20, 2004
CompletedJune 24, 2005
April 1, 2004
April 15, 2004
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify 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;
- +2 more criteria
You may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 15, 2004
First Posted
April 20, 2004
Last Updated
June 24, 2005
Record last verified: 2004-04