Resistant ovarian cancer
Conditions
Interventions
Topotecan 1.0mg/m2 iv, day1-5,etoposide 50mg/body, p.o., day 1-21, repeat every 28 days
Sponsors
Kyorin University, School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven ovarian cancer. 2) Patient who has at lesion. (measurable or unmeasurable) 3) Disease progression at the platinum containing chemotherapy or until 6 months from the last chemotherapy and patients with recurrent after the Liposomal Doxorubicin single agent therapy. 4) More than 4 weeks after last chemotherapy. 5) Patients aged of 20 to 79 years. 6) ECOG performance status (PS): 0-2 7) Sufficient function of main organ and bone marrow filled the following criteria: Leukocyte counts, 4,000/mm3 or over and 12,000/mm3 or under. Neutrophil counts, 2,000/mm3 or over. Platelets, 100,000/mm3 or over. Hemoglobin, 8.0g/dL or over. AST and ALT, 100 IU/L or less. Serum bilirubin, 1.5mg/dL or less. Serum creatinin, x1.5 of ULN or less. 8) Patients with 3 months of life expectancy. 9) Written informed consent from the patients.
Exclusion criteria
Exclusion criteria: 1) Patients with severe infectious disease and/or serious complication. 2) Patients who have severe gastrointestinal injury and/or gastrointestinal bleeding. 3) Patients who have necessary ascites and/or pleural effusion of measures. 4) Patients with interstitial pneumonia. 5) Patients with ileus. 6) Patients with active brain metastases. 7) Patients with active double cancer. 8) Patients who carried out bone marrow transplantation. 9) Patients who have the past of serious hypersensitivity. 10) Patients who are pregnant or who are at risk of pregnancy, or those who desire to become pregnant during their participation. 11) Patients who have uncontrolled diabetes mellitus. 12) Patients who received topoisomerase I inhibitor and/or topoisomerase II inhibitor containing chemotherapy within 6 months. 13) Inappropriate patients for this study judged by the physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate, Safty | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate,Progression-free survival, Overall survival, | — |
Countries
Japan
Contacts
Public ContactYoichi Kobayashi
Kyorin University, School of Medicine Obstetrics and Gynecology
Outcome results
None listed