Carboplatin + paclitaxel vs carboplatin + stealth liposomal doxorubicin. A randomised multicentre trial.
- Conditions
- Recurrent ovarian cancerCytologic / histologic diagnosis of stage IC-IV ovarian cancer
- Registration Number
- EUCTR2004-002399-40-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 530
Inclusion criteria
*Cytologic / histologic diagnosis of stage IC-IV ovarian cancer
*Indication for chemotherapy treatment
*Age < 75 years.
*Life expectancy of at least 3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria
*Previous or concomitant malignant neoplasia (not including basocellular or
spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided
they are being adequately treated).
*Performance Status (ECOG) _ 3.
*Previous chemotherapy treatment
*Heart disease (heart failure, myocardial heart attack during the 6 months prior to
the trial, atrioventricular block of any degree, serious arrhythmia)
*Leukocytes < 4000/mm3, neutrophils < 2000/mm3, platelets < 100000/mm3
*Modifications of renal function (Creatininaemia _ 1.25 times the upper normal
limit) or liver function (SGOT or SGPT _ 1.25 times the upper normal limit)
*Present or suspected haemorrhagic syndromes
*Uncooperative and/or unreliable patients
*Patients' inability to access the centre due to area of residence
*Refusal of informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of the experimental combination (carboplatin + liposomal<br>doxorubicin), with the efficacy of the standard combination (carboplatin + paclitaxel),<br>as first-line treatment of ovarian cancer patients. ;Secondary Objective: Toxicity.<br>;Primary end point(s): Primary end-point<br>To compare the efficacy, in terms of progression-free survival (PFS) of the<br>experimental combination of carboplatin + liposomal doxorubicin, compared with the<br>standard combination of carboplatin + paclitaxel, in the first line treatment of ovarian<br>cancer patients.<br>
- Secondary Outcome Measures
Name Time Method