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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000002691 |
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Date of registration:
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29/10/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase II trial of combination chemotherapy consisting of pegylated liposomal doxorubicin and carboplatin in patients with recurrent ovarian cancer
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Scientific title:
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Phase II trial of combination chemotherapy consisting of pegylated liposomal doxorubicin and carboplatin in patients with recurrent ovarian cancer - Phase II trial of PLD-carboplatin in recurrent ovarian cancer patients |
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Date of first enrolment:
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2009/10/01 |
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Target sample size:
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33 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003283 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Address:
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35 Shinanomachi, Shinjuku, Tokyo, 160-8582
Japan |
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Telephone:
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Email:
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Affiliation:
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Keio University, School of Medicine Keio Center for Clinical Research |
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Name:
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Toshiaki Saito |
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Address:
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3-1-1 Notame, Minami-ku, Fukuoka 811-1395, Japan
Japan |
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Telephone:
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Email:
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Affiliation:
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National Kyushu Cancer Center Gynecology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Patients with severe complications or active infection. 2. Patients with prior diagnosis of malignancy are not eligible. Exceptions are: -non-melanoma skin cancer, and carcinoma in situ. -other malignancies curatively treated and > 5 years without evidence of recurrence. 3. Patients with massive pleural effusion and/or ascites. 4. Patients with massive pericardial fluid. 5. Patients with unstable angina or those who have had a myocardial infarction within the past 90 days. 6. Patients with brain metastasis who have symptoms or require administration of steroid or antihydropic. 7. Patients who have received prior bone marrow transplantation, or high-dose chemotherapy and hematopoietic stem cell transplantation. 8. Patients who have received prior chemotherapy consisting of pegylated liposomal doxorubicin. 9. Patients who have participated in other clinical trials. 10. Patients who have received prior chemotherapy consisting of doxorubicin. 11. Patients with history of hypersensitivity reactions to the components of pegylated liposomal doxorubicin. 12. Patients who are pregnant, lactating, and have pregnant possibility or intention. 13. Patients who are decided to be ineligible for this trial by the investigators.
Age minimum:
20years-old
Age maximum:
75years-old
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer in late relapse (>6 months) after 1st-line chemotherapy
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Intervention(s)
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Combination chemotherapy consisting of pegylated liposomal doxorubicin (30 mg/m2 iv, day1) and carboplatin (AUC=5 iv, day1) will be administered every 4 weeks. Patients is planned to receive at least 4 cycles of combination treatment and 16 cycles as the upper limit unless disease progression or unacceptable toxicity is observed.
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Primary Outcome(s)
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Best overall response (Response rate)
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Secondary Outcome(s)
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The incidence of adverse events, overall survival, and progression-free survival.
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Source(s) of Monetary Support
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Janssen Pharmaceutical K.K.
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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