None listed
Conditions
Interventions
Intervention1: Lipodox: 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
Control Interventi
Sponsors
TTY Biopharm Company Limited
Eligibility
Inclusion criteria
Inclusion criteria: a. histologically proven ovarian cancer of FIGO stage III/IV b. treatment with five to six cycles of Paclitaxel / Platinum regimen c. 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 ECOG 0, 1, 2 e. adequate hematopoietic function is defined as below:  ANC  1,500/uL  Platelets  100,000/uL f. adequate organ function is defined as below:  Total bilirubin  1.5  ULN  ALT / AST  1.5  ULN (5.0 x ULN if hepatic metastasis)  Serum creatinine ≦ 1.5 × ULN g. age 20-75 years old h. life expectancy equal or longer than 3 months i. ability to understand and willingness to sign a written informed consent document
Exclusion criteria
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 study c. 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  Pancratitis d. 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 study f. radiotherapy within 4 weeks prior to entering the study g. concurrent chemotherapy, radiotherapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period h. mental status is not fit for clinical trial i. pregnant or breast feeding women j. potential child-bearing women unless using a reliable and appropriate contraceptive method.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine progression free survival of Pegylated Liposomal Doxorubicin (PLD) / Carboplatin or without in patients with advanced ovarian cancerTimepoint: 48 months since randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
|  To assess and compare Quality-of-Life in each arm  To determine the overall survival (OS) in each arm  To assess the safety profiles Timepoint: 48 Months since randomisation | — |
Countries
India
Contacts
Public ContactDr Alben Sigamani
Assistant Professor
Outcome results
None listed