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Phase I/II trial of paclitaxeal and cisplatin in patients with recurrent ovarian cancer

Phase I/II trial of paclitaxeal and cisplatin in patients with recurrent ovarian cancer - Phase I/II trial of paclitaxeal and cisplatin in patients with recurrent ovarian cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015496
Enrollment
30
Registered
2014-10-21
Start date
2011-03-05
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

Patients with hypersensitivity reaction to carboplatin (ovarian cancer, fallopian tubal cancer, primary peritneal cancer)

Interventions

Patients were treated with paclitaxeal followed by cisplatin weekly. Paclitaxeal dose was fixed at 80mg/m2. Cisplatin dose was tailored to individualized maximum repeatable dose. Stating dose of cispl

Sponsors

SchooMedicine, Chiba university
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1)Patients with a histological diagnosis of ovarian cancer (including fallopian tube, or primary peritoneal carcinoma) 2)Prior one regimens chemotherapy is required. Patients had hypersensitivity reactions to carboplatin. 3)Patients have at least one measurable disease. 4)No chemotherapy within 2 weeks prior to the registration 5)Patients who are 20 years old or older and younger than 79 years old at the enrollment 6)Performance status:ECOG 0-2 7)Adequate bone marrow, renal, and hepatic function 8)Patients who are expected to survive more than 3 months. 9)Patients who have signed an approved informed consent.

Exclusion criteria

Exclusion criteria: 1)Patients who have a history of hypersensitivity to paclitaxeal. 2)Patients with active infection 3)Patients with severe complications (Heart disease, uncontrolleddiabetes, malignant hypertension, or bleeding tendency) 4)Patients with other cancer within the past 5 years 5)Patients with myocardial infarction within 6 months or angina attack. 6)Patients who are inappropriate to enter this study with any safety reasons,judged by the treating physician.

Design outcomes

Primary

MeasureTime frame
Hypersensitivity reactions to cisplatin

Secondary

MeasureTime frame
Adverse events Progression free survival response rate (disease control rate) overall survival tolerability patients QOL

Countries

Japan

Contacts

Public ContactShinichi Tate, M.D.

Chiba university Hospital Gynecology

state@faculty.chiba-u.jp043-222-7171

Outcome results

None listed

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