A Single Arm Phase II Trial of Intraperitoneal Chemotherapy with Paclitaxel and Cisplatin after Optimal Debulking Surgery for Ovarian, Peritonuem and Fallopian Tube Cancers assessing the feasibility, toxicity and effects on quality of life of a modified GOG 172 (Gynaecologic Oncology Group) intraperitoneal (IP) regimen.

ANZGOG, University of Sydney0 个研究点目标入组 35 人开始时间: 2006年12月5日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1.Stage III epithelial ovarian cancer, primary peritoneal cancer or primary fallopian tube cancers.2.Optimal surgical debulking with residual disease = 1cm.3.IP catheter in-situ4.Platelets = 100 X 109/L; Absolute Neutrophil Count (ANC) = 1.5 X 109/L5.Serum creatinine = 1.5 UNL (Upper Normal Limit) and creatinine clearance (CRCL) = 55ml/min (as calculated by Cockroft-Gault formula; Appendix 2).6.Serum bilirubin = 1.5 UNL and ALT (Amino Alanine Transferase) , Alk Phos (Alkaline Phosphatase) = 3 UNL7.ECOG PS (Eastern Cooperative Oncology Group Performance Status) 0,1 or 28.Able to commence treatment within 6 weeks of primary surgical treatment9.Informed consent obtained.

•1.Invasive cancer within the last 5 years other than basal cell or localized squamous cell carcinoma of the skin.2.Significant intercurrent illness that will interfere with the chemotherapy during the trial such as a.Known HIV (Human Immunodeficiency Virus) infection b.Active infectionc.Myocardial infarction within the previous 6 months or significant cardiac disease resulting in an inability to tolerate the intravenous fluid load as required for administration of cisplatind.Severe lung disease which in the investigators opinion would limit the patients ability to tolerate large volumes of intra-abdominal fluids.3.Any grade I or greater peripheral neuropathy (NCI CTC version 3.0).4.Clinically significant sensori-neural hearing impairment or tinnitus which may be exacerbated by cisplatin (Audiometric abnormalities without corresponding clinical deafness will not be grounds for exclusion).5.Previous cytotoxic chemotherapy for malignancy6.Previous abdominal or pelvic radiation treatment.7.Significant intra-abdominal adhesions as determined by the surgeon at time of primary surgery.8.Rectosigmoid or left colon resection at time of primary debulking surgery.9.Active intraabdominal sepsis10.Medical or psychiatric condition that compromises the patients ability to give informed consent.

发起方

ANZGOG, University of Sydney