Phase II randomized trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Mullerian carcinoma (tailored dose vs optimal dose chemotherapy)
Phase 2
Recruiting
- Conditions
- Patients with platinum refractory and resistant Mullerian carcinoma (ovarian cancer, fallopian tubal, primary peritoneal cancer)
- Registration Number
- JPRN-UMIN000006999
- Lead Sponsor
- School of Medicine, Chiba University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 64
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients who have a history of hypersensitivity to gemcitabine and irinotecan. 2)Patients with active infection 3)Patients with severe complications (Heart disease, uncontrolleddiabetes, malignant hypertension, or bleeding tendency) 4)Patients with other cancer within the past 5 years 5)Patients with myocardial infarction within 6 months or angina attack. 6)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 Progression free survival
- Secondary Outcome Measures
Name Time Method Adverse event Response Rate ( disease control rate) Overall Survival Tolerability Patient QO