Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to study efficacy and the effects on quality of life in women with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and paclitaxel compared to those treated with standard every 3 weeks schedule of the same chemotherapy.

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

Details

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

Criteria

Inclusion Criteria:

• Cytologic or histologic diagnosis of ovarian carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma, stage IC-IV

• Indication for chemotherapy

• Age > 18 years

• Life expectancy of at least 3 months

Exclusion Criteria:

• Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix, and synchronous endometrioid carcinoma Stage Ib or less for the uterus, with ovarian tumor Stage II or higher)

• Performance Status (ECOG) > or = 3.

• Previous chemotherapy

• Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)

• Neutrophils < 2000 x mm3, platelets < 100000 x mm3

• Inadequate renal function (creatinine > or = 1.25 x normal values) or liver function (ALT or AST > or = 1.25 x normal values)

• Present or suspected hemorrhagic syndromes

• Inability to comply with protocol and follow-up

• Inability to access study site for clinical visits

• Refusal of informed consent