Active trials


Back to Gynaecological Cancer

 

ICON6
ICON8
OUTBACK
OVAR16
PARAGON
REZOLVE
Symptom Benefit

ICON6

A randomised, placebo-controlled trial of concurrent cediranib (AZD2171)(with platinum-based chemotherapy) and concurrent and maintenance cediranib in women with platinum-sensitive relapsed ovarian cancer

Trial Summary:

ICON6 is a randomised (2:3:3), three-arm, double-blind, placebo-controlled multicentre Gynaecological Cancer InterGroup trial. It is a phase III multistage trial of cediranib given in combination with platinum-based chemotherapy, and continued as maintenance therapy, in patients with relapsed platinum-sensitive ovarian cancer (defined as relapsed disease 6 or more months after completion of first-line treatment).

Eligibility:Women with platinum-sensitive relapsed ovarian cancer
Registration ID:ACTRN12610000160033
Participation:International
Australian Lead Group:ANZGOG
Status:Follow-up
Activation Date:1/01/2011
Chairs:J Lederman (international), Michelle Vaughan (Australia)
Contact:icon6@ctc.usyd.edu.au

ICON8

An international phase III randomised trial of dose-fractionated chemotherapy compared to standard three-weekly chemotherapy, following immediate primary surgery or as part of delayed primary surgery, for women with newly diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer.

Trial Summary:

The ICON8 trial is testing whether giving chemotherapy at the smaller dose more often is better than the traditional once every 3 weeks that has been the norm for many years.

Supported By: MRC (UK) and Cancer Australia
Eligibility:Women with newly diagnosed high-risk early stage or advanced stage epithelial, fallopian tube or primary peritoneal carcinoma, and ovarian carcinosarcoma.
Registration ID:NCT01654146
Participation:International
Australian Lead Group:ANZGOG
Status:Open
Activation Date:27/11/2013
Chairs:Andrew Dean (Australia)
Contact:icon8@ctc.usyd.edu.au

OUTBACK

Phase III trial of addition of adjuvant chemotherapy to standard chemoradiation as primary treatment for cervical cancer

Trial Summary:

The OUTBACK trial is designed for women with locally advanced cervical cancer suitable for primary treatment with chemoradiation. Its aim is to determine whether addition of adjuvant chemotherapy to standard cisplatin-based chemoradiation improves overall survival.

Eligibility:Women with locally advanced cervix cancer
Registration ID:ACTRN12610000732088
Participation:International
Australian Lead Group:ANZGOG
Status:Open
Activation Date:10/03/2011
Chairs:Linda Mileshkin (Australia)
Contact:outback@ctc.usyd.edu.au

OVAR16

A phase III study to evaluate the efficacy and safety of pazopanib monotherapy versus placebo in women whose disease has not progressed after first-line chemotherapy for epithelial ovarian, fallopian tube or primary peritoneal cancer

Trial Summary:

This study is for women who have FIGO stages II-IV ovarian, fallopian tube or primary peritoneal cancer that has not progressed after first-line chemotherapy. Approximately 900 women are being randomly allocated to pazopanib, 800 mg daily, or placebo. Treatment continues for 52 weeks unless the participant dies or discontinues treatment. The primary objective of the study is to determine whether pazopanib prolongs progression-free survival. Throughout the study, all participants have safety and efficacy assessments, which include physical examinations, blood tests, CT or MRI scans and questionnaires.

Supported By: GlaxoSmithKline; Australia New Zealand Gynaecological Oncology Group (ANZGOG); Arbeitsgemeinschaft Gynackologisehe Onkologie (AGO) Ovarian Cancer Study Group
Eligibility:Women with epithelial ovarian, fallopian tube, or primary peritoneal cancer
Registration ID:ACTRN12609000591257
Participation:International
Australian Lead Group:ANZGOG
Status:Follow Up
Activation Date:14/08/2009
Chairs:Michael Friedlander (Australia)
Contact:ovar16@ctc.usyd.edu.au

PARAGON

Phase II study of anastrozole in gynaecological cancers (Gynaecological Cancer InterGroup study)

Trial Summary:

The aim of this study is to assess the activity of anastrozole, in women with oestrogen-receptor- or progesterone-receptor-positive recurrent or metastatic gynaecological cancers. It includes selected patients with epithelial ovarian cancer, endometrial cancers, miscellaneous gynaecological sarcomas and granulosa and sex-cord stromal tumours of the ovary.

Supported By: Cancer Australia and NCGC
Eligibility:Women with potentially hormone-responsive gynaecological cancers
Registration ID:ACTRN12610000796088
Participation:International
Australian Lead Group:ANZGOG
Status:Open
Activation Date:16/12/2011
Chairs:Michael Friedlander (Australia)
Contact:paragon@ctc.usyd.edu.au

REZOLVE

A phase II study to evaluate the safety and potential palliative benefit of intraperitoneal bevacizumab in patients with symptomatic ascites due to advanced chemotherapy resistant ovarian cancer

Trial Summary:

This study will evaluate the activity of intraperitoneal bevacizumab in delaying reaccumulation of ascites in patients with chemotherapy resistant ovarian, peritoneal and fallopian tube cancers and symptomatic ascites.

Supported By: Cancer Australia
Eligibility:Women with a chemotherapy resistant ovarian, peritoneal or fallopian tube cancer and symptomatic ascites that has recurred within 4 weeks or therapeutic drainage and who are no longer receiving chemotherapy.
Registration ID:ACTRN12611000801910
Participation:Australia
Australian Lead Group:ANZGOG
Status:Open
Activation Date:1/11/2013
Chairs:Katrin Sjoquist
Contact:rezolve@ctc.usyd.edu.au

Symptom Benefit

Does palliative chemotherapy improve symptoms in women with recurrent ovarian cancer?

Trial Summary:

Most patients with ovarian cancer present with advanced disease and, following debulking surgery, receive platinum-based chemotherapy. Patients who relapse less than 6 months after completing first-line chemotherapy are classified as 'platinum resistant' and have a median survival of 6-9 months. Patients whose disease progresses while they are on treatment are classified as having 'platinum refractory' disease.

This is a quality-of-life study measuring subjective improvement as well as objective response to estimate the benefit of palliative chemotherapy in women with platinum-resistant or refractory ovarian cancer.  Objective response rates to chemotherapy in these patients are low. No large, randomised, controlled trials have yet reported the effect of systemic chemotherapy on symptom palliation and quality of life in patients with relapsed ovarian cancer.

Eligibility:Women with platinum-resistant epithelial ovarian cancer
Registration ID:ACTRN12607000603415
Participation:International
Australian Lead Group:ANZGOG
Status:Open
Activation Date:8/05/2008
Chairs:Michael Friedlander and Phyllis Butow (Australia)
Contact:symptombenefit@ctc.usyd.edu.au