Patient population
diarrhoea, gastrointestinal disease, malignancy, fracture, vessel infiltration, ulcer
IN SITU CARCINOMA, BRAIN METASTASIS, FALLOPIAN TUBE CANCER, GASTROINTESTINAL DISEASE, CANCER, DISEASE, LONG QT SYNDROME, BASAL CELL CARCINOMA, SECONDARY, ARTERIAL HYPERTENSION, ONCOLOGY, ULCER, BLEEDING DIATHESIS
Women age ≥ 18 years with histologically confirmed ovarian, peritoneal or fallopian tube cancer who had progressed during platinum therapy (platinum refractory) or within 6 months after completing primary or secondary platinum-containing therapy (platinum resistant) or within 12 months after primary platinum-containing therapy (intermediate platinum-sensitive) were eligible for study treatment. Additional inclusion criteria were measurable disease as described per RECIST 1.1 or elevated cancer antigen (CA)- 125 as described by GCIG criteria; ability to swallow and retain oral medication; Eastern Cooperative Oncology Group (ECOG) status 0 or 1; life expectancy of ≥ 12 weeks; adequate bone marrow, liver, renal and cardiac function (defined as haemoglobin ≥ 9 g/dl, absolute neutrophile count ≥ 1500 cells per μl, platelet count ≥ 100 cells per μl, prothrombin time, international normalised ratio or partial thromboplastin time ≤ 1.2 × upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 × ULN, calculated creatinine clearance ≥ 50 ml/min or serum creatinine ≤ 1.5 mg/dl). Women of childbearing potential had to agree to adequate contraception throughout the study.Patients were ineligible if they had received more than two previous chemotherapies, previous topotecan at any time or had surgery, radiotherapy or concurrent antineoplastic therapy up to two weeks before inclusion into study. Other exclusion criteria were prior diagnosis of any malignancy ≤ 5 years before study entry (except successfully treated in situ carcinomas or skin basal cell carcinoma), brain metastasis, any kind of gastrointestinal disease that could interfere with the study medication, grade 3 or 4 diarrhoea, ulcer or bleeding diathesis, uncontrolled arterial hypertension, clinically relevant heart condition or a long QT syndrome > 450 ms, endobronchial lesions with vessel infiltration or fracture.Ethical review committees approved the study protocol, amendments, and other relevant study documentation. The study was conducted according to the Declaration of Helsinki (1996), the International Conference on Harmonization Good Clinical Practice recommendations, and provisions of the German Medicines Act. All patients provided written informed consent before study start. Alcedis as independent clinical research institute was responsible for data monitoring.