Leiomyosarcoma of Uterus
Conditions
Interventions
Irinotecan 100 mg/m2 q 4 weeks day 1,8,15 2 courses or more
Sponsors
Japanese Gynecologic Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Pathologicaly confirmed Leiomyosarcoma of the uterus with apparent metastasis 2) Unable to completely remove the tumors for newly diagnosed or recurrent disease 3) 20 years-old<=age<75 years-old 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 5) Less than on regimen of prior chemotherapy that does not include CPT-11. * Patients with prior radiotherapy is eligible. * Patients must have at least 4 weeks since prior chemotherapy, BRM, radiotherapy 6) At least 1 uni-dimensional measurable lesion >= 20 mm by conventional CT or MRI OR >= 10 mm by helical CT scan 7) Adequate bone marrow, cardiac, pulmonry functions. Lab data must be within 7 days from the registration - Absolute neutrophil count:>= 1,500/mm3 - Platelet count:>= 100,000/mm3 - Hemoglobin:>= 9.0g/dL - AST/ALT:<100 IU/L - Bilirubin:<1.5mg/dL - Serum creatinine:< 1.5mg/dL 8) Reasonable expectation for more than 12 weeks of survival period. 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with previous CPT-11 chemotherapy. 2) Patients with any history of serious drug reactions or hypersensitivity to CPT-11 3) Patients with massive pleural, cardiac effusion, and/or ascites 4) Patients with symptomatic brain metastasis 5) Patients with active infections 6) Patients with diarrhea (watery stool) five times or more in a day 7) Patients with unstable angina, history of cardiac infarction within 6 months, or arrhythmia that requires medical treatment 8) Patients with intestinal paralysis or illeus 9) Patients with interstitial pneumonia or pulmonary fibrosis 10) Patients with active concomitant malignancy. * Patients with history of any other malignancy within 5 years are ineligible. * Patients with carcinoma in situ or intramucosal malignancy that was curable with local therapy are eligible. 11) Patients with uncontrolled diabetes mellitus 12) Patients who are under the treatment with Atzanavir 13) Patients during pregnancy or breast-feeding, or unwilling to the use of contraception 14) Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Response | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression- Free Survival,Time to Progression,Toxicity,Overall Survival | — |
Countries
Japan
Contacts
Public ContactSatoshi Takeuchi ,MD,Ph.D.
JGOG2042 Coordinating Office Department of Obstetrics and Gynecology, Iwate Medical University
Outcome results
None listed