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

UMIN ID: UMIN000001837

Registered date:01/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: platinum resistant and taxane pretreated ovarian cancer
• Date of first enrollment: 2009/04/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): etoposide 50mg/m2, p.o., day 1-21, irinotecan 70mg/m2 iv, day1, 15, repeat every 28 days, up to 6cycles

Outcome(s)

• Primary Outcome: response rate
• Secondary Outcome: adverse event, progression free survival, overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare