Study to determine the possibility of treating women with ovarian and related cancers with chemotherapy, some of which is given directly into the abdomen as well as into the vein. It will also determine how safe it is, what side-effects it causes and how it affects quality of life.

Phase 2

Completed

• Conditions: Ovarian Cancer; Peritoneum Cancer; Fallopian tube Cancer; Cancer of the ovary, peritonuem and fallopian tube; Cancer - Ovarian and primary peritoneal

• Registration Number: ACTRN12606000502538
• Lead Sponsor: ANZGOG, University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the feasibility of giving treatment as prescribed. Feasibility will include the number of cycles of treatment received, the dose intensity and requirement for dose modification (delay, reduction, omission).[Outcome checked after treatment given. Treatment is given for 6 cycles given at 3 weekly intervals]