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)

Phase 1

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

• Registration Number: JPRN-UMIN000002879
• Lead Sponsor: Kansai Clinical Oncology Group

Brief Summary

48 patients were enrolled, and 46 were eligible to receive the treatment. The patients median age was 61 years . two cases of carcinosarcoma, and two cases of clear cell carcinoma by histology. Twenty-nine participants received >=6 cycles of chemotherapy. The RR was 71.3% .

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-12
• Study Completion: 2010-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To define the RD of PLD in combination with TXT.

Secondary Outcome Measures

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