Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer

MITO-2

The purpose of this study is to compare the effectiveness (progression free survival) of the experimental combination of carboplatin + liposomal doxorubicin with the standard combination of carboplatin + paclitaxel in first line treatment of patients with ovarian cancer. Secondary objectives are to evaluate overall survival, quality of life, objective response rate, and toxicity.

2003-01-01

2023-12-01

2023-12-01

Active (not recruiting)

Early phase I

820

Inclusion Criteria: * Cytologic / histologic diagnosis of stage Ic-IV ovarian cancer * Indication for chemotherapy treatment * Age 75 years or less * Life expectancy of at least 3 months 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) \> 2 * Previous chemotherapy treatment * Heart disease (heart failure, myocardial heart attack within 6 months prior to randomization, atrioventricular block of any degree, serious arrhythmia) * Leukocytes \< 4000/mm3, neutrophils \< 2000/mm3, platelets \< 100000/mm3 * Impaired renal function (creatinine \> 1.25 times the upper normal limit) or liver function (SGOT or SGPT \> 1.25 times the upper normal limit) * Present or suspected hemorrhagic syndromes * Uncooperative and/or unreliable patients * Patient's inability to access the center * Refusal of informed consent

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 820, 'type': 'ACTUAL'}}

2023-03-27