Phase I study of pegylated liposomal doxorubicin (PLD) in combination with docetaxel (TXT) in recurrent or refractory ovarian cancer (epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma)

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000002879
• Date of registration: 12/12/2009
• Prospective Registration: Yes
• Primary sponsor: Kansai Clinical Oncology Group
• Public title: Phase I study of pegylated liposomal doxorubicin (PLD) in combination with docetaxel (TXT) in recurrent or refractory ovarian cancer (epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma)
• Scientific title: Phase I study of pegylated liposomal doxorubicin (PLD) in combination with docetaxel (TXT) in recurrent or refractory ovarian cancer (epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma) - KCOG G-0901
• Date of first enrolment: 2010/01/01
• Target sample size: 12
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003455
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Phase I

Countries of recruitment

Japan

Contacts

• Name: Kensuke Hori
• Affiliation: kansai rousai hospital Obstetrics and gynecology

• Name: Kensuke Hori
• Affiliation: kansai rousai hospital Obstetrics and gynecology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) Patients with complications (severe complications or active systemic infection) that may affect the study or assessment of the drugs) 2) Patients with diagnosis of active multiple cancers (synchronous multiple cancers and metachronous multiple cancers within 5 years of disease free interval: exceptions are basal cell carcinoma and squamous cell carcinoma, carcinoma in situ that is curatively treated by local treatment, and intramucosal carcinoma like lesion.) 3) Patients with angina or myocardial infarction within the past 90 days (previous day of the enrollment is defined as day 1 and up to 90 days) 4) Patients who have brain metastasis with symptoms or patients with brain metastasis requiring administration of steroid or antihydropic 5) Patients who have received prior bone marrow transplantation, or high-dose chemotherapy and hematopoietic stem cell transplantation 6) Patients who have received prior chemotherapy consisting of anthracycline (including PLD) or docetaxel 7) Patients with history of hypersensitivity reactions to the components of anthracycline, taxane, or liposomal doxorubicin (MPEG-DSPE, hydrogenated lecithin, cholesterol, ammonium sulfate, histidine, sucrose, hydrochloric acid, sodium hydroxide) 8) Patients who are pregnant, lactating, and have pregnant possibility or intention 9) Patients who are decided to be ineligible for this study by the principal investigator (or subinvestigator)

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

Health Condition(s) or Problem(s) studied

Recurrent or refractory ovarian cancer (epithelial ovarian carcinoma, fallopian tubal carcinoma, or primary peritoneal carcinoma)

Intervention(s)

PLD (25-30mg/m2 ,day1)+TXT (50-60mg/m2 , day 1)

Primary Outcome(s)

To define the RD of PLD in combination with TXT.

Secondary Outcome(s)

To evaluate the best overall response (response rate) and safety of PLD in combination with TXT.

Source(s) of Monetary Support

None

Ethics review

Status: YES
Approval date: 30/07/2009
Contact:

[e-mail]

Kansai Rosai Hospital

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 10/08/2020
• Date Completed: 01/12/2010
• URL: https://www.kcog.net/%E5%A9%A6%E4%BA%BA%E7%A7%91%E3%82%B0%E3%83%AB%E3%83%BC%E3%83%97/%E9%80%B2%E8%A1