Phase III Randomized Trial of Maintenance Pegylated Liposomal Doxorubicin (PLD) / Carboplatin versus without in Patients with Advanced Ovarian Cancer
- Registration Number
- CTRI/2008/091/000016
- Lead Sponsor
- TTY Biopharm Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine progression free survival of Pegylated Liposomal Doxorubicin (PLD) / Carboplatin or without in patients with advanced ovarian cancerTimepoint: 48 months since randomisation<br><br>
- Secondary Outcome Measures
Name Time Method &#61548;To assess and compare Quality-of-Life in each arm<br>&#61548;To determine the overall survival (OS) in each arm<br>&#61548;To assess the safety profiles<br><br>Timepoint: 48 Months since randomisation