WEEKLY vs EVERY 3 WEEK CARBOPLATIN + PACLITAXEL IN PATIENTS WITH OVARIAN CANCER: RANDOMIZED MULTICENTER STUDY - MITO-7

• Conditions: PATIENTS WITH OVARIAN CANCER; MedDRA version: 9.1Level: LLTClassification code 10007107Term: Cancer of ovary

• Registration Number: EUCTR2008-001754-40-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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
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 malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervice, and synchronousl carcinoma endometrioid Stage Ib or less for the uterus, with ovarian tumor Stage II or higher) · Performance Status (ECOG) ³ 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 ³ 1.25 x normal values) or liver function (ALT or AST ³ 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified