CT-2106 for the Second Line Treatment of Ovarian Cancer
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian, CT-2106
Eligibility Criteria
Inclusion Criteria: Patients with advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly At least one measurable lesion according to RECIST ECOG performance status 0 or 1 at least 18 years old Adequate haematological function Adequate renal and hepatic functions Normal coagulation parameters Exclusion Criteria: Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of > 12 months Pregnant or lactating patients Prior treatment with camptothecins Presence or history of CNS metastasis or carcinomatous leptomeningitis; Current active infection per investigator assessment; Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis; Current history of chronic diarrhea >= grade 1 (CTCAE version 3); Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed; Other uncontrolled, serious illness or medical condition, as determined by the investigator; Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation; Concurrent treatment with any other anti-cancer therapy; Known HIV positivity or AIDS-related illness; Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.