None listed
Conditions
Interventions
The MAX study is a multi-centre, stratified, randomised, phase II/III study that aims to compare the safety and efficacy of the combination of capecitabine and bevacizumab and the combination of capecitabine, Mitomycin C (MMC) and bevacizumab, with that of capecitabine monotherapy in patients with previously untreated metastatic colorectal cancer. Treatment will continue until disease progression, unless there is unacceptable toxicity or either the patient or physician requests cessation of tre
The MAX study is a multi-centre, stratified, randomised, phase II/III study that aims to compare the safety and efficacy of the combination of capecitabine and bevacizumab and the combination of capecitabine, Mitomycin C (MMC) and bevacizumab, with that of capecitabine monotherapy in patients with previously untreated metastatic colorectal cancer. Treatment will continue until disease progression, unless there is unacceptable toxicity or either the patient or physician requests cessation of treatment.
Sponsors
Australian Gastro-Intestinal Trials Group (AGITG)
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a)Histological diagnosis of metastatic colorectal cancer. b)Any patient in whom the investigator considers capecitabine monotherapy appropriate. c)Evaluable or non-evaluable disease as assessed by CT scan. d)ECOG performance status 0, 1 or 2. Patients with PS2 should have serum albumin >30 g/L. e)No prior chemotherapy agents or anti-angiogenic biological agents (e.g. anti VEGF) for treatment of advanced disease. Adjuvant chemotherapy (including antiangiogenic therapy) which was completed > 6 months ago is allowed. f)Adequate bone marrow function with platelets > 100 X 109/l; neutrophils > 1.5 X 109/l. g)Adequate renal function, with calculated creatinine clearance >30 ml/min (Cockcroft and Gault). For patients with creatinine clearance <50 ml/min the starting dose of capecitabine may not be greater than 2000 mg/m2/d (See section 6.1) h)Adequate hepatic function with serum total bilirubin < 1.5 X upper limit of normal range. i)Life expectancy of at least 12 weeks. j)No concurrent uncontrolled medical conditions. k)No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer treated with curative intent >2 years previously without evidence of relapse. l)Women and partners of women of childbearing potential must agree to use adequate contraception. m)Written informed consent.
Exclusion criteria
No exclusion criteria
Outcome results
None listed