Carboplatin + paclitaxel vs carboplatin + stealth liposomal doxorubicin. A randomised multicentre trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002399-40-DK

Enrollment

530

Registered

2005-03-22

Start date

2005-05-11

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent ovarian cancer Cytologic / histologic diagnosis of stage IC-IV ovarian cancer

Interventions

Product Name: Pegylated Liposomal Doxorubicin Product Code: 9254 Pharmaceutical Form: Concentrate for solution for infusion Product Name: Carboplatin Pharmaceutical Form: Concentrate for solution for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria *Cytologic / histologic diagnosis of stage IC-IV ovarian cancer *Indication for chemotherapy treatment *Age =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of the experimental combination (carboplatin + liposomal doxorubicin), with the efficacy of the standard combination (carboplatin + paclitaxel), as first-line treatment of ovarian cancer patients. ;Secondary Objective: Toxicity. ;Primary end point(s): Primary end-point To compare the efficacy, in terms of progression-free survival (PFS) of the experimental combination of carboplatin + liposomal doxorubicin, compared with the standard combination of carboplatin + paclitaxel, in the first line treatment of ovarian cancer patients.	—

Measure

Time frame

Main Objective: To compare the efficacy of the experimental combination (carboplatin + liposomal doxorubicin), with the efficacy of the standard combination (carboplatin + paclitaxel), as first-line treatment of ovarian cancer patients. ;Secondary Objective: Toxicity. ;Primary end point(s): Primary end-point To compare the efficacy, in terms of progression-free survival (PFS) of the experimental combination of carboplatin + liposomal doxorubicin, compared with the standard combination of carboplatin + paclitaxel, in the first line treatment of ovarian cancer patients.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026