Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000025639
Ethics application status
Approved
Date submitted
19/07/2005
Date registered
19/07/2005
Date last updated
9/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The MAX study
Scientific title
The MAX Study: A randomised phase II/III study to determine the relative toxicity of Mitomycin C, Avastin and X eloda in patients with untreated metastatic colorectal cancer, and to compare the effects of Mitomycin C, Avastin and Xeloda in patients with untreated metastatic colorectal cancer on progression-free survival
Secondary ID [1] 87 0
National Clinical Trials Registry: NCTR561
Universal Trial Number (UTN)
Trial acronym
MAX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic colorectal cancer 88 0
Condition category
Condition code
Cancer 109 109 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 34 0
Treatment: Drugs
Comparator / control treatment
.
Control group
Active

Outcomes
Primary outcome [1] 135 0
Progression free survival
Timepoint [1] 135 0
Measured after 450 patients have completed 1 year of follow-up
Secondary outcome [1] 302 0
Treatment related toxicity
Timepoint [1] 302 0
Measured after 450 patients have completed 1 year of follow-up
Secondary outcome [2] 303 0
Treatment response
Timepoint [2] 303 0
Measured after 450 patients have completed 1 year of follow-up
Secondary outcome [3] 304 0
Overall survival
Timepoint [3] 304 0
Measured after 450 patients have completed 1 year of follow-up
Secondary outcome [4] 305 0
Symptoms of disease, treatment and quality of life
Timepoint [4] 305 0
Measured after 450 patients have completed 1 year of follow-up
Secondary outcome [5] 306 0
Cost of therapy and assessment of gain in quality adjusted progression free survival
Timepoint [5] 306 0
Measured after 450 patients have completed 1 year of follow-up

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation made from a central site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation sequence generated by ClinTrials software with adaptive minimisation. Stratification by age (=/>65y vs <65y), WHO Performance status and Institution
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
27/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 128 0
New Zealand
State/province [1] 128 0
Country [2] 129 0
United Kingdom
State/province [2] 129 0

Funding & Sponsors
Funding source category [1] 148 0
Commercial sector/Industry
Name [1] 148 0
Roche Products Australia - educational grant
Country [1] 148 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australian Gastro-Intestinal Trials Group (AGITG)
Address
88 Mallett St
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 106 0
Government body
Name [1] 106 0
NHMRC Clinical Trials Centre
Address [1] 106 0
88 Mallett St
Camperdown NSW 2050
Country [1] 106 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4390 0
Border Medical Oncology
Ethics committee address [1] 4390 0
Ethics committee country [1] 4390 0
Australia
Date submitted for ethics approval [1] 4390 0
Approval date [1] 4390 0
Ethics approval number [1] 4390 0
Ethics committee name [2] 4391 0
Nepean Cancer Care Centre
Ethics committee address [2] 4391 0
Ethics committee country [2] 4391 0
Australia
Date submitted for ethics approval [2] 4391 0
Approval date [2] 4391 0
Ethics approval number [2] 4391 0
Ethics committee name [3] 4392 0
Royal Adelaide Hospital
Ethics committee address [3] 4392 0
Ethics committee country [3] 4392 0
Australia
Date submitted for ethics approval [3] 4392 0
Approval date [3] 4392 0
Ethics approval number [3] 4392 0
Ethics committee name [4] 4393 0
Lismore Base Hospital
Ethics committee address [4] 4393 0
Ethics committee country [4] 4393 0
Australia
Date submitted for ethics approval [4] 4393 0
Approval date [4] 4393 0
Ethics approval number [4] 4393 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35760 0
Address 35760 0
Country 35760 0
Phone 35760 0
Fax 35760 0
Email 35760 0
Contact person for public queries
Name 9223 0
Ms Burcu Cakir
Address 9223 0
NHMRC Clinical Trials Centre
Locked bag 77
Camperdown NSW 2050
Country 9223 0
Australia
Phone 9223 0
+61 2 95625000
Fax 9223 0
+61 2 95625094
Email 9223 0
[email protected]
Contact person for scientific queries
Name 151 0
Dr Niall Tebbutt
Address 151 0
Austin Hospital
Heidelberg VIC 3084
Country 151 0
Australia
Phone 151 0
+61 3 9496 3217
Fax 151 0
+61 3 9457 6698
Email 151 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo The addition of bevacizumab to standard chemothera... [More Details]
Study results articleYes Capecitabine, bevacizumab, and mitomycin in first-... [More Details]

Documents added automatically
No additional documents have been identified.