- MAX Study
Trial Status
Completed
Cancer Type
Colorectal Cancer
Protocol Title
A randomised phase II/III study to evaluate the role of Mitomycin C, Avastin and Xeloda in patients with untreated metastatic colorectal cancer.
Purpose of the Study
This is a phase II/III study which evaluated the role of Mitomycin C (MMC), Avastin and Xeloda in metastatic colorectal cancer. The primary aim was 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 would be randomised to receive capecitabine, capecitabine plus bevacizumab or the combination of capecitabine, bevacizumab and MMC.
Principal Investigator
Prof Niall Tebbutt
DETAILED INFORMATION AVAILABLE
Available online at ClinicalTrials.Gov, please click here
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