NIPH Clinical Trials Search

UMIN ID: UMIN000001837

Registered date:01/04/2009

A PhaseII trial of oral etopocide and iv irinotecan for patients with platinum resistant and taxane pretreated ovarian cancer(JCOG0503)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedplatinum resistant and taxane pretreated ovarian cancer
Date of first enrollment2009/04/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)etoposide 50mg/m2, p.o., day 1-21, irinotecan 70mg/m2 iv, day1, 15, repeat every 28 days, up to 6cycles


Primary Outcomeresponse rate
Secondary Outcomeadverse event, progression free survival, overall survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
Include criteria
Exclude criteria1. 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

Related Information


public contact
Name Koji Matsumoto
Address 13-70,Kitaouji-cho,Akashi,Hyogo 673-8558,Japan Japan
Telephone 078-929-1151
Affiliation JCOG0503 Coordinating Office Hyogo Cancer Center medical oncology division
scientific contact
Name Ikuo Konishi
Address 54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto,606-8507,Japan Japan
Affiliation Graduate school of medicine, Kyoto University Division of Gynecology and Obstetrics