platinum resistant and taxane pretreated ovarian cancer
Conditions
Interventions
etoposide 50mg/m2, p.o., day 1-21, irinotecan 70mg/m2 iv, day1, 15, repeat every 28 days, up to 6cycles
Sponsors
Japan Clinical Oncology Group(JCOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Cytologically or histologically proven ovarian, tubal, ore peritoneal cancer 2. Platinum resistant disease 3. Taxne pretreated disease 4. Age: 20-75 years old 5. PS: 0-2 6. One of the followings, or both of them i) patients have measurable lesion ii) patients have asseable lesion with elevated CA125 (more than 70) 7. No prior treatment with irinotecan, topotecan, or etopocide 8. No prior radiation to abdomen 9. Oral intake without parental nutrition 10. One of the followings i) no drainage to effusion, or ascites in last 28 days ii) no effusion or ascites to be drainaged 11. One of the followings i) no chemotherapy or surgery in last 28 days ii) no hormonal or biologic therapy in last 14 days 12. Patients without sever organ dysfunction 13. Written informed concsent
Exclusion criteria
Exclusion criteria: 1. Patients with a concomitant or prior invasive malignancy (except intramucosal malignancy which are curable with local therapy) who have had any evidence of the disease within the last 5 years 2. Patients who cannot undergo treatment due to the past history of mental disorder or the central nerve disorder 3. Women during pregnancy or breast-feeding 4. Patients who have been treated with the systemic steroids medication 5. Patients with active infection 6. Patients with uncontrollable hypertension 7. Patients with uncontrollable diabetes 8. Patients with history of myocardial infarction, unstable angina, or heart failure within six months 9. Patients with bowel obstruction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event, progression free survival, overall survival | — |
Countries
Japan
Contacts
Public ContactKoji Matsumoto
JCOG0503 Coordinating Office Hyogo Cancer Center medical oncology division
Outcome results
None listed