Patients with platinum-refractory and &
Conditions
Interventions
Patients were treated with irinotecan followed by gemcitabine on days 1 and 8 every 3 weeks. Irinotecan dose was fixed at 50 mg/ m2, and gemcitabine dose was tailored to individualized maximum repeata
Sponsors
School of Medicine, Chiba University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patients with a histological diagnosis of ovarian cancer (including fallopian tube, or primary peritoneal carcinoma) 2)Prior two regimens chemotherapy is required. Platinum-resistant disease is based on the most recent exposure to a platinum-based regimen and is defined as progressive disease within 6 months of completing the prior therapy. 3)Patients have at least one measurable disease. 4)No chemotherapy within 2 weeks prior to the registration 5)Patients who are 20 years old or older and younger than 75 years old at the enrollment 6)Performance status:ECOG 0-2 7)Adequate bone marrow, renal, and hepatic function 8)Patients who are expected to survive more than 3 months. 9)Patients who have signed an approved informed consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event Response Rate ( disease control rate) Overall Survival Tolerability Patient QOL | — |
Countries
Japan
Contacts
Public ContactShinichi Tate , M.D.
School of Medicine, Chiba University Department of Reproductive medicine
Outcome results
None listed