Phase III Randomized Trial of Maintenance Pegylated Liposomal Doxorubicin (PLD)/ Carboplatin versus without in Patients with Advanced Ovarian Cancer

Phase 3

Completed

• Conditions: Advanced ovarian cancer; Cancer - Ovarian and primary peritoneal

• Registration Number: ACTRN12607000329460
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 122

Inclusion Criteria

To be eligible for inclusion, each patient must fulfill all of the following criteria:a. histologically proven ovarian cancer of International Federation of Gynecology and Obstetrics stage III/IVb. treatment with five to six cycles of Paclitaxol / Platinum regimenc. attainment of a clinical defined complete response (ie, no cancer-related symptom ; normal physical examination, CT scan of the abdominal/pelvis and chest x-ray ; CA-125 level < 35 U/mL) d. performance status of Eastern Cooperative Oncology Group 0, 1, 2 e. adequate hematopoietic function is defined as below:- Absolute Neutrophil Count > 1,500/uL- Platelets > 100,000/uLf. adequate organ function is defined as below:- Total bilirubin < 1.5 X Upper Limit of Normal (ULN)- Alanine aminotranferase / Aspartate aminotransferase < 1.5 X ULN (<5.0 x ULN if hepatic metastasis) - Serum creatinine < 1.5 × ULNg. age 20-75 years oldh. life expectancy equal or longer than 3 monthsi. ability to understand and willingness to sign a written informed consent document

Exclusion Criteria

a. presence of CNS metastases (including clinical suspicion)b. other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the studyc. presence of other serious concomitant illness which can affect or elevate the value of CA-125, e.g.;- Autoimmune disease- Sarcoidosis- Chronic active hepatitis- Pericarditis- Cirrhosis of liver- Abdominal tuberculosis- Pancratitisd. presence of other serious concomitant illness which might be aggravated by study medication:- Uncontrolled infection (active serious infections that are not controlled by antibiotics)- Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.- History of ventricular arrhythmia or congestive heart failure.e. surgery within 2 weeks prior to entering the studyf. radiotherapy within 4 weeks prior to entering the studyg. concurrent chemotherapy, radiotherapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study periodh. mental status is not fit for clinical triali. pregnant or breast feeding womenj. potential child-bearing women unless using a reliable and appropriate contraceptive method.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival[At baseline, by history and Physical Exam/Pelvic exam on every visit, and abdominal pelvic CT scan at baseline and every year from the start of treatment until progression during the study (including clinical suspicion).]

Secondary Outcome Measures

Name	Time	Method
Overall survival, Quality-of-Life, safety profile[At baseline, by history and PE/PV on every visit and abdominal pelvic CT scan at baseline and every year from the start of treatment until progression during the study (including clinical suspicion).]