None listed
Conditions
Brief summary
In the current study, we will use Lipo-Dox® in combination with carboplatin as maintenance chemotherapy in advanced epithelial ovarian patients who have achieved clinical complete remission after 5-6 courses of taxane/platinum based first-line chemotherapy. All eligible subjects will randomize to arm A or arm B. Arm A: Subjects will receive PLD(Lipo-Dox) 30 mg/m2 intravenously (iv) over 1 hour on day 1 and follow by Carboplatin 4 AUC intravenous infusion for 30 minutes in a 28-day cycle for maximum six cycles. Arm B: Subjects will not receive any treatment. Therapeutic Assessment includes progression free survival, quality-of-life, overall survival, and safety profiles.
Interventions
Maintenance Pegylated Liposomal Doxorubicin (PLD) 30mg/m2/ Carboplatin Area Under the Curve = 4 in 28-day cycles for 6 courses versus observation (no treatment) after complete remission of first-line chemotherapy.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Outcome results
None listed