A phase II study of Irinotecan (CPT-11) for Leiomyosarcoma of Uterus
- Conditions
- eiomyosarcoma of Uterus
- Registration Number
- JPRN-C000000448
- Lead Sponsor
- Japanese Gynecologic Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 35
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tumor Response
- Secondary Outcome Measures
Name Time Method Progression- Free Survival,Time to Progression,Toxicity,Overall Survival