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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000550

Enrollment

100

Registered

2006-12-18

Start date

2001-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage Ic-IV epithelial ovarian cancer

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed epithelial ovarian cancer with International Federation of Gynecology and Obstetrics stage Ic to IV 2. Not received any prior therapy including chemo- and radiotherapy, and treatment with biologic response modifier. 3. Eastern Cooperative Oncology Group performance status of 0 to 2 4. At least 20 and less than 75 years of age 5. A life expectancy of at least 3 months 6. A white blood cell count between 4000/mm3 and 12000/mm3 7. A neutrophil count >= 2000/mm3 8. A platelet count >= 100000/mm3 9. Hemoglobin >= 9.0 g/dL 10. Serum bilirubin <= 1.5 mg/dL 11. Aspartate aminotransferase and alanine aminotransferase <= 1.5 x the upper normal limit (UNL) 12. Alkaline phosphatase <= 2.5 x UNL 13. Serum creatinine <= 1.5 mg/dL 14. Creatinine clearance >= 60 mL/min 15. Written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Safety, feasibility, clinical response, overall survival	—

Countries

Japan

Contacts

Public ContactDaisuke Aoki

School of Medicine, Keio University Department of Obstetrics and Gynecology

03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026