Safety and efficacy assessments
anaemia, bleeding, Tumour, neutropenia, febrile neutropenia, fever, toxicity, thrombocytopenia, rash, tumour, Toxicity, alopecia, nausea, vomiting
ANAEMIA, ADVERSE EVENT, BLEEDING, TUMOUR, NEUTROPENIA, FEBRILE NEUTROPENIA, THROMBOCYTOPENIA, TUMOUR, ALOPECIA
Toxicity was assessed for each cycle, graded according to the NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose-limiting toxicity were defined as: grade 3 or 4 non-hematologic toxicity, grade 3 thrombocytopenia combined with bleeding (removed with third protocol amendment, March 26, 2014) or grade 4 thrombocytopenia, grade 4 neutropenia lasting ≥ 7 days or febrile neutropenia defined as ANC < 1000/µl concurrent with fever, any grade 2 and more toxicity of cycle 1 other than nausea, vomiting, rash, alopecia or anaemia, that persisted over 35 days.At study baseline gynaecological and physical examination, weight control, vital signs, electrocardiogram (ECG), ECOG, laboratory parameters (haemoglobin, leucocytes, neutrophils, platelets, partial thromboplastin time (PTT), prothrombin time [international normalised ratio] (PT-INR), aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, bilirubin, alkaline phosphatase, urea, albumin, creatine [and creatine clearance if applicable], TSH, free T4, sodium, magnesium, and potassium) and quality of life questionnaires EORTC-QLQ C30 and OVAR 28 were obtained. Further laboratory evaluation (haemoglobin, leucocytes, neutrophils, platelets, PTT and PT-INR) was performed weekly during the phase I and the first cycle of the phase II study. Prior to every further treatment cycle ECOG and physical examination with addition of cardiac monitoring per ECG every 4 weeks were performed. During pazopanib maintenance the safety monitoring was continued every four weeks, with assessment of liver parameters (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, bilirubin) biweekly (weeks 5, 7, 9) and from the first follow-up every three weeks of pazopanib intake. During the follow-up assessment of survival, physical status, tumour response, ECOG and quality of life were obtained every three months.At baseline radiological assessment CT or MRI (physician’s choice) of measurable and non-measurable tumour lesions (≤ 28 days prior study enrolment) and CA-125 monitoring were achieved. For response assessment, radiological evaluation (RECIST) and CA-125 measurements (GCIG criteria) were done every 12 weeks from the start of treatment and during the maintenance phase. Tumour response had to be confirmed by a second examination, no independent review of outcome was necessary.