MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Doxorubicin; Liposomal doxorubicin; Paclitaxel

Criteria

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