Advanced or recurrent endometrial cancer
Conditions
Interventions
Irinotecan hydrochloride
Sponsors
Kurume University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed (endometrial cytology or surgical histopathology) recurrence of endometrial cancer (excluding carcinosarcoma and sarcoma) 2. Patients with a history of up to 1 regimen of prior chemotherapy 1). At least 4 weeks have elapsed since the final date of treatment with the previous chemotherapy regimen, or there are no carry-over effects. 2). At least 4 weeks have elapsed since the final date of radiotherapy, or there are no carry-over effects. 3). At least 2 weeks have elapsed since the final dose of metabolic antagonists, hormone therapy, or immunotherapy, or there are no carry-over effects. 3.Patients aged from 20 years to younger than 75 years 4.Patients with a performance status (ECOG) of 0 to 1 5.Presence of measurable lesions (Compliance with RECIST: tumor diameter: 20 mm on CT scans or 10 mm on helical CT scans) 6.Patients for whom the results of previous imaging studies performed within 28 days before enrollment are available 7.Patients who are expected to survive for 3 months or longer 8.Patients with the following bone marrow, liver, and kidney functions based on data obtained within 1 week before enrollment 1)White-cell count: 3000/mm3< 2)Neutrophil count: 1500/mm3< 3)Platelet count: 100,000/mm3< 4)Hemoglobin level: 9.0 g/dL< 5)Total bilirubin level:<1.5 mg/dL 6)AST (GOT): <2.5 times the institutional upper limit of normal 7)ALT (GPT):<2.5 times the institutional upper limit of normal 8)Serum creatinine level: the institutional upper limit of normal 9.Patients from whom written informed consent to participate in the study has been directly obtained.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, safety, OS | — |
Countries
Japan
Contacts
Public ContactShin Nishio
Kurume University School of Medicine Department of Obstetrics and Gynecology
Outcome results
None listed