CLINICAL PHASE II STUDY OF IROFULVEN IN COMBINATION WITH IRINOTECAN IN PATIENTS WITH ADVANCED SOLID TUMORS GASTROINTESTINALES
- Conditions
- -C26 Malignant neoplasm of other and ill-defined digestive organsMalignant neoplasm of other and ill-defined digestive organsC26
- Registration Number
- PER-056-02
- Lead Sponsor
- MGI PHARMA, INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Patients with advanced gastrointestinal solid tumors without standard chemotherapy treatment or progressed to standard chemotherapy.
Disease measurable / evaluable by the RECIST criteria.
Age 18 years.
ECOG Performance Status (PS): 0-1
Life expectancy> 3 months.
Previous chemotherapy with topoisomerase I inhibitors
Previous intestinal obstruction / subostruction not completely resolved or chronic diarrhea, chronic enteropathy, extensive intestinal resection (> hemicolectomy).
Patients with radiant treatment in more than 35% of the bone marrow after admission to the study.
Presence of any serious concomitant systemic disorder incompatible with the study.
Presence of any disorder of the central nervous or psychiatric system that may hinder the participation of the patient in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:RECIST criterion<br>Measure:Evaluate objective tumor response rate.<br>Timepoints:every 2 months<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The results of clinical observations and laboratory tests will form the basis for the description of the profile of adverse experiences of irofiilven and irinotecan administered in combination.<br>Measure:-Evaluation of safety (description of qualitative and quantitative toxicities)<br>Timepoints:every 2 months<br>