Multicenter phase II study of docetaxel and cisplatin as primary chemotherapy in patients with stage Ic-IV epithelial ovarian cancer

UMIN ID: UMIN000000550

Registered date:18/12/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Stage Ic-IV epithelial ovarian cancer
• Date of first enrollment: 2001/11/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Combination of docetaxel and cisplatin was administered every 4 weeks. Docetaxel (70 mg/m2) was administered intravenously over 1-2 hours. Cisplatin (60 mg/m2) was administered intravenously over 2-3 hours with adequate hydration before and after. Patients were planned to receive at least 6 courses of combination treatment unless disease progression or unacceptable toxicity was observed.

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Safety, feasibility, clinical response, overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 1. Received only exploratory laparotomy 2. Confirmed infection 3. Fever (a body temperature >= 38 degrees Celsius) 4. Severe complication 5. Active concomitant malignancy 6. Brain metastasis 7. Interstitial pneumonia or lung fibrosis confirmed by chest X-ray or computed tomography 8. Pleural or peritoneal effusion that required treatment 9. Pericardial effusion 10. Motor paralysis, peripheral nervous system dysfunction or edema of grade 2 or more 11. History of severe drug allergy 12. Previously received long-term corticosteroid therapy 13. Pregnant or lactating women, or women who intended to become pregnant during the study

Related Information

• Primary Sponsor: A group for a study of DOC/CDDP combination chemotherapy for ovarian cancer
• Source(s) of Monetary Support: NO