Phase II Clinical Trial of Monotherapy with Irinotecan Hydrochloride (CPT-11) for Advanced or Recurrent Endometrial Cancer
- Conditions
- Advanced or recurrent endometrial cancer
- Registration Number
- JPRN-UMIN000017079
- Lead Sponsor
- Kurume University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 26
Not provided
1.Patients with a history of treatment with topoisomerase I inhibitors (irinotecan, nogitecan, etc.) 2.Patients with liver dysfunction (jaundice) or serious renal dysfunction 3.Patients with serious drug allergies (hypersensitivity) 4.Patients with active double cancers 5.Patients who have or are suspected to have clinically problematic infections 6.Patients with poorly controlled hypertension or diabetes mellitus 7.Patients who have marked electrocardiographic abnormalities or clinically problematic cardiac disease 8.Patients with severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema, etc.) 9.Patients with a history of clinically problematic mental disorders, central nervous system disorders, or cerebrovascular/cranial nerve disease 10. Patients with fresh gastrointestinal bleeding, intestinal paralysis, intestinal obstruction, or peptic ulcer 11.Patients with pleural effusion, ascites, or pericardial effusion requiring removal with the use of a drain 12.Patients with brain metastasis or who are suspected to have brain metastasis on the basis of clinical symptoms 13.Patients with diarrhea (watery stool) 14.Patients who are receiving atazanavir sulfate 15.Patients who are continuously receiving systemic administration of steroids (oral or intravenous infusion) 16.Pregnant women, breast-feeding women, or women who may (want to) become pregnant 17.Patients who are considered ineligible for participation in the study by the physician responsible (partially responsible) for treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method