Peter Gibbs-Clinical trials

Peter Gibbs-Clinical trials

Clinical trials

1. Prospective studies to define the prognostic significance and clinical utility of ctDNA informed therapy after surgery for early stage cancers

A reliable biomarker of minimal residual disease could have a major impact on adjuvant therapy decision making and the development of new adjuvant treatments.

Our initial studies in colorectal cancer and pancreatic cancer have shown that circulating tumour DNA (ctDNA) is a powerful prognostic biomarker. Patients with detectable ctDNA after curative intent surgery have been shown to have a markedly elevated risk of recurrence (well in excess of the average for that patient population), whereas patients with no detectable ctDNA have a much lower risk of recurrence (much less that the average for that patient population).

Prospective randomized studies are exploring the potential of a ctDNA directed approach to adjuvant therapy whereby patients with detectable ctDNA have treatment intensified and those with undetectable ctDNA have less intense treatment. World first randomized studies have completed recruitment (stage II colon cancer) or are ongoing (stage III colon cancer, locally advanced rectal cancer and pancreatic cancer). An observational study has been initiated in ovarian cancer.

Project resource: Dynamic-III clinical trial information

Team members: Associate Professor Jeanne Tie is the clinical lead for the colorectal studies, Dr Belinda Lee for the pancreas study and Dr Sumitra Ananda for the ovarian study. Her research involves understanding prognostic and predictive molecular biomarkers in colorectal cancer, with a focus on exploring the clinical applications of liquid biopsies (circulating tumour DNA) in colorectal cancer. 

Contact the project manager: 

 

2. Registry Randomised Controlled Trials (rRCTs)

These studies are addressing simple but important questions in the routine of common cancers, exploring issues not addressed in conventional clinical trials such as the optimal treatment sequence, combination or duration of available therapies.

Contact: registrytrials@mh.org.au

 

ALT-TRACC Alternating oxaliplatin and irinotecan doublet schedules versus continuous doublet chemotherapy in previously untreated metastatic colorectal cancer - A Treatment of Recurrent and Advanced Colorectal Cancer registry-based prospective randomised trial.

Project description: This study enrolls patients with treatment naïve metastatic colorectal cancer where initial treatment using all three cytotoxic agents (FOLFOXIRI) has been shown to improve survival outcomes but also to have significant toxicity. The current study builds on an initial randomized phase II study that showed that alternating doublets could provide the treatment benefits of using all three drugs, without adding adverse events.

Eligibility criteria: Patients commencing first line doublet chemotherapy for metastatic colorectal cancer

Principal investigators: Dr Vanessa Wong and Professor Peter Gibbs

Study contact: Michael Harold michael.harold@mh.org.au   

Project resourceAustralian and New Zealand Clinical Trials Registry, ANZCTR; ACTRN12618001944224

 

EX-TEM: Phase III Trial of Extended Temozolomide in Newly Diagnosed Glioblastoma 

Cancer type and stage: Brain cancer, glioblastoma

Project description: The purpose of this study is to determine if an extended use of a chemotherapy medication (temozolomide) after radiation improves survival outcome in patients with newly diagnosed glioblastoma. This follows promising retrospective data from sites that have used this approach, but randomized data is required to validate this as a strategy to be used in routine care.

Eligibility criteria: Newly diagnosed patients with histologically confirmed glioblastoma (WHO grade IV) and radiologically stable or responding disease following concurrent chemoradiation and six cycles of post-radiation temozolomide

Principal investigator: Dr Lucy Gately

Study contact: Megan Dumas megan.dumas@mh.org.au   

Project resourceAustralian and New Zealand Clinical Trials Registry, ANZCTR

 

REAL-Pro: Registry-based Study of Enzalutamide vs Abiraterone assessing cognitive function in ELderly patients with Metastatic Castration-Resistant Prostate Cancer

Project description: The purpose of this study is to see if there is a difference in cognitive decline between elderly patients treated with two common prostate cancer medications (enzalutamide and abiraterone acetate)

Eligibility: Male aged 75 or over with a diagnosis of metastatic prostate cancer (cancer that has spread outside the prostate)

Principal investigator: Dr Ben Tran

Study contact: Kristina Zlatic kristina.zlatic@mh.org.au

Project resourceAustralian and New Zealand Clinical Trials Registry, ANZCTR

 

 

3. Prospective studies of patient derived tumour organoid informed treatment selection

Project description: FORECAST-1 – Feasibility of using Organoid Response to find Effective Treatments for patients with Colorectal cancer After failure of Standard Therapy

Cancer type and stage: Metastatic colorectal cancer having failed standard therapies

Summary: This is a feasibility study to evaluate the potential for real-time use of tumour organoid response to predict clinical benefit from available anti-cancer therapies for mCRC. This study will collect fresh tumour biopsies from patients with refractory mCRC for tumour organoid culture.

Eligibility criteria: Patients who have failed two lines of therapy for mCRC

Principal investigator: Dr Margaret Lee

Study contact: Helen Brasier Helen.Brasier@mh.org.au

Further informationFORECAST-1 clinical trial information

 

4. Establishing biobanks of colorectal and pancreatic cancer models for the pursuit of personalised therapies

Summary: Through collection of fresh tumour and adjacent normal tissue specimens, this protocol aims to establish a living biobank, including establishment of organoid cultures and PDX models. The ultimate aim is to use this resource to improve treatment selection and identify potential new biomarkers and treatment options

Eligibility criteria: All stages of colorectal and pancreatic cancer, glioblastoma

Principal investigator: Dr Margaret Lee (colorectal), Dr Belinda Lee (pancreas) and Dr Lucy Gately (glioblastoma)

Study contact: Helen Brasier Helen.Brasier@mh.org.au