None listed
Conditions
Interventions
Irofulven is administered intravenously 0.40 mg / kg (the total dose should not exceed 50 mg) and Irinotecan 125 mg / m2 both drugs on days 1 and 15.
Sponsors
MGI PHARMA, INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:RECIST criterion Measure:Evaluate objective tumor response rate. Timepoints:every 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Measure:-Evaluation of safety (description of qualitative and quantitative toxicities) Timepoints:every 2 months | — |
Countries
Argentina, Belgium, France, Peru
Outcome results
None listed