ICON8: Weekly Chemotherapy in Ovarian Cancer

Exclusion Criteria

• •Non-epithelial ovarian cancer, including malignant mixed Müllerian tumours (carcinosarcomas)
• •Peritoneal cancer that is not of Müllerian origin, including mucinous histology
• •Borderline tumours (tumours of low malignant potential)
• •Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)
• •Previous malignancies within 5 years prior to randomisation apart from: adequately treated carcinoma in-situ of the cervix, breast ductal carcinoma in-situ, non-melanomatous skin cancer; or previous/synchronous early-stage endometrial cancer defined as stage IA (FIGO 2009) grade 1 or 2 endometrioid cancers with no lymphovascular space invasion
• •Pre-existing sensory or motor neuropathy grade ≥ 2
• •Evidence of any other disease/metabolic dysfunction that in the opinion of the investigator would put the subject at high-risk of treatment-related complications or prevent compliance with the trial protocol
• •Planned intraperitoneal cytotoxic chemotherapy
• •Any previous radiotherapy to the abdomen or pelvis
• •Sexually active women of childbearing potential not willing to use adequate contraception (e.g. oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) for the study duration and at least six months afterwards
• •Pregnant or lactating women
• •Treatment with any other investigational agent prior to protocol defined progression
• •Known hypersensitivity to carboplatin, paclitaxel or their excipients (including cremophor)