MAX Study

A randomised phase II/III study to  evaluate  the  role  of Mitomycin C, Avastin and Xeloda in patients with untreated metastatic colorectal cancer.

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Trial Status

Completed

Cancer Type

Colorectal Cancer

Aim

This is a phase II/III study evaluating the role of Mitomycin C (MMC), Avastin and Xeloda in metastatic colorectal cancer. The primary aim is to determine an optimal low toxicity regimen which could be used in a broad range  of patients. Patients for whom capecitabine monotherapy is considered appropriate will be randomised to receive capecitabine, capecitabine plus bevacizumab or the combination of capecitabine, bevacizumab and MMC.

Trial Status

Completed

Cancer Type

Colorectal Cancer

Publication Reference

CRX 2008            
Comparison of ethical and regulatory processes in two multi- centred, multi-regional oncology clinical trials: an Australian perspective (abstract submitted).

ASCO 2008         
International multi-centre randomised Phase II/III study of Capecitabine (Cap), bevacizumab (Bev) and mitomycin C (MMC) in metastatic colorectal cancer (mCRC): Final safety analysis of the AGITG MAX trial (poster).

ASCO 2008         
Comparing utilities for advanced colorectal cancer valued from societal and cancer-patients’ perspectives using baseline data from the MAX study (presentation)

ASCO GI 2008 
AGITG MAX Trial- Capecitabine (Cap), bevacizumab (Bev) and mitomycin C (MMC) in metastatic colorectal cancer (mCRC): safety analysis of 400 patients in an international multi-centre randomised Phase II/III study (updated results of 471 patients) (poster)

ICTS 2007           
The MAX Study: MAXimising trial outcomes in a multi- centred, multi-regional clinical trial (poster)

COSA 2007          
Comparing utilities for advanced colorectal cancer valued from societal and cancer-patients’ perspectives using baselinedata from the MAX study of the Australasian Gastro- Intestinal Trials Group (AGITG) (poster)

ACT 2007            
The MAX Study: MAXimising trial outcomes in a multi- centred, multi-regional clinical trial (poster)

SCT 2007
The MAX Study: MAXimising trial outcomes in a multi- centred, multi-regional clinical trial (poster)

Aim

This is a phase II/III study evaluating the role of Mitomycin C (MMC), Avastin and Xeloda in metastatic colorectal cancer. The primary aim is to determine an optimal low toxicity regimen which could be used in a broad range  of patients. Patients for whom capecitabine monotherapy is considered appropriate will be randomised to receive capecitabine, capecitabine plus bevacizumab or the combination of capecitabine, bevacizumab and MMC.

Principal Investigator

A/Prof Niall Tebbutt