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.

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000502538

Acronym

TRIPOD

Enrollment

Registered

2006-12-05

Start date

2007-09-14

Completion date

2009-12-11

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Recent studies by the US Gynecologic Oncology Group have found that patients, who are given chemotherapy directly into the abdominal cavity as well as through a vein, live longer than those who are given chemotherapy through a vein only. TRIPOD is a study which will determine if it is possible and safe to treat ovarian cancer patients, in Australia and New Zealand with chemotherapy given directly into the abdomen as well as through a vein. This study will enroll at least 35 patients which will take approximately 1 year. The aim of the study is to determine if it is possible to treat women with ovarian cancer 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.

Interventions

IP catheter either at or within 6 weeks of primary surgery. Trial registration following catheter insertion. Chemotherapy Regimen Paclitaxel 135mg/m2 IV (Intravenous) over 3 hours (Day 1) Cisplatin 75mg/m2 IP (Day 2) Paclitaxel 60mg/m2 IP (Day 8) Treatment will consist of 6 cycles given at 3 weekly intervals

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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.

Outcome results