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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00294359




Registration number
NCT00294359
Ethics application status
Date submitted
21/02/2006
Date registered
22/02/2006
Date last updated
22/08/2007

Titles & IDs
Public title
The MAX Study: Mitomycin C, Avastin and Xeloda in Patients With Untreated Metastatic Colorectal Cancer
Scientific title
The 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
Secondary ID [1] 0 0
AG0501CR
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mitomycin C; Capecitabine; Bevacizumab

Treatment: Drugs: Mitomycin C; Capecitabine; Bevacizumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase II: - treatment related toxicity
Timepoint [1] 0 0
Primary outcome [2] 0 0
Phase III: - progression free survival
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Phase II: - treatment response
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Phase III:
Timepoint [2] 0 0
Secondary outcome [3] 0 0
- treatment related toxicity
Timepoint [3] 0 0
Secondary outcome [4] 0 0
- treatment response
Timepoint [4] 0 0
Secondary outcome [5] 0 0
- overall survival
Timepoint [5] 0 0
Secondary outcome [6] 0 0
- symptoms of disease, treatment and quality of life
Timepoint [6] 0 0
Secondary outcome [7] 0 0
- cost of therapy and assessment of gain in quality-adjusted progression free survival
Timepoint [7] 0 0

Eligibility
Key inclusion criteria
- Histological diagnosis of colorectal cancer

- Metastatic disease that is not resectable

- Age > 18 years

- Any patient in whom the investigator considers capecitabine monotherapy appropriate

- Measurable and/or non-measurable disease as assessed by CT scan

- ECOG performance status 0, 1 or 2. Patients with PS2 should have serum albumin >30 g/L

- No prior chemotherapy except for adjuvant chemotherapy given in association with (i)
complete resection of primary colon or rectal cancer provided there is no clinical,
radiological or biochemical evidence of relapse for at least 6 months after completion
of adjuvant treatment and/or (ii) complete resection of limited colorectal metastases
to liver and/or lung provided there is no clinical, radiological or biochemical
evidence of relapse for at least 6 months after completion of adjuvant treatment

- Adequate bone marrow function with platelets > 100 X 109/l; neutrophils > 1.5 X 109/l
i) 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 7.1)

- Adequate hepatic function with serum total bilirubin < 1.5 X upper limit of normal
range

- Life expectancy of at least 12 weeks

- No other concurrent uncontrolled medical conditions

- No other malignant disease apart from 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

- Women and partners of women of childbearing potential must agree to use adequate
contraception

- Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Medical or psychiatric conditions that compromise the patient's ability to give
informed consent or to complete the protocol

- Patients with a lack of physical integrity of the upper gastrointestinal tract, or
known malabsorption syndromes.

- Uncontrolled hypertension

- Active bleeding disorders within the last 3 months

- Patients on full anticoagulation with warfarin. (Patients who require full
anticoagulation and who wish to participate in the study should be converted to low
molecular weight heparin). (Note: patients receiving full anticoagulation with low
molecular weight heparin should have no evidence of tumour invading or abutting major
blood vessels on any prior CT scan)

- Participation in any investigational drug study within the previous 8 weeks

- Patients with uncontrolled clinically significant cardiac disease, arrhythmias or
angina pectoris

- Patients with a history of acute myocardial infarction or cerebrovascular accident
within the last 12 months

- Regular use of aspirin (>325mg/day) or NSAIDs (low dose aspirin (<325 mg/d), or
occasional use of NSAIDs is acceptable)

- CNS metastases

- Major surgical procedure within the last 28 days

- Serious non-healing wound, ulcer or bone fracture

- 24 hour urinary protein > 2g/ 24 hours ( performed if urine dipstick > 1+ )

- Pregnancy or lactation

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2007
Sample size
Target
333
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Lismore Hospital - Lismore
Recruitment hospital [2] 0 0
Newcastle Mater Hospital - Newcastle
Recruitment hospital [3] 0 0
Bankstown Hospital - Sydney
Recruitment hospital [4] 0 0
Campbelltown Hospital - Sydney
Recruitment hospital [5] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [6] 0 0
Nepean Hospital - Sydney
Recruitment hospital [7] 0 0
North Shore Private Hospital - Sydney
Recruitment hospital [8] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [9] 0 0
Royal North Shore Hosp - Sydney
Recruitment hospital [10] 0 0
St George Hospital - Sydney
Recruitment hospital [11] 0 0
Sydney Cancer Centre, Concord Repat General Hospital - Sydney
Recruitment hospital [12] 0 0
Sydney Cancer Centre, Royal Prince Alfred Hospital - Sydney
Recruitment hospital [13] 0 0
Westmead Hospital - Sydney
Recruitment hospital [14] 0 0
Tamworth Base Hospital - Tamworth
Recruitment hospital [15] 0 0
Tweed Heads Hospital - Tweed Heads
Recruitment hospital [16] 0 0
Southern Medical Daycare - Wollongong
Recruitment hospital [17] 0 0
Royal Brisbane Hospital - Brisbane
Recruitment hospital [18] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [19] 0 0
Queen Elizabeth Hospital / Lyell McEwin Centre - Adelaide
Recruitment hospital [20] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [21] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [22] 0 0
Bendigo Public Hospital - Bendigo
Recruitment hospital [23] 0 0
Geelong Hospital - Geelong
Recruitment hospital [24] 0 0
Austin Health - Melbourne
Recruitment hospital [25] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [26] 0 0
Frankston Hospital - Melbourne
Recruitment hospital [27] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [28] 0 0
Peter MacCallum Cancer Institute - Melbourne
Recruitment hospital [29] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [30] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [31] 0 0
Fremantle Hospital - Perth
Recruitment hospital [32] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [33] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [34] 0 0
St John of God Hospital, Subiaco - Perth
Recruitment postcode(s) [1] 0 0
- Lismore
Recruitment postcode(s) [2] 0 0
- Newcastle
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
- Tamworth
Recruitment postcode(s) [5] 0 0
- Tweed Heads
Recruitment postcode(s) [6] 0 0
- Wollongong
Recruitment postcode(s) [7] 0 0
- Brisbane
Recruitment postcode(s) [8] 0 0
- Adelaide
Recruitment postcode(s) [9] 0 0
- Hobart
Recruitment postcode(s) [10] 0 0
- Bendigo
Recruitment postcode(s) [11] 0 0
- Geelong
Recruitment postcode(s) [12] 0 0
- Melbourne
Recruitment postcode(s) [13] 0 0
- Wodonga
Recruitment postcode(s) [14] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Palmerston

Funding & Sponsors
Primary sponsor type
Other
Name
Australasian Gastro-Intestinal Trials Group
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Although it is possible to cure bowel cancer when it is detected at an early stage, in many
cases it may spread to involve other organs and in these cases is generally incurable.
Chemotherapy prolongs survival and improves quality of life in such patients, but standard
chemotherapy for this disease has not been defined.

There are several possible chemotherapy treatments for patients with bowel cancer, which has
spread to other organs. However, these treatments are only partly effective and only work for
a limited period of time. Most treatments are associated with a number of possible side
effects which may have a detrimental effect on quality of life. Thus, it is imperative that
more effective treatments with the lowest possible risk of side effects are developed.

Previous studies have shown that the addition of a new type of antibody treatment
(bevacizumab) to an intensive combination chemotherapy regimen improved survival in patients
with advanced bowel cancer and extended the time before tumours began to grow. However,
intensive chemotherapy is likely to only be a suitable treatment for a proportion of patients
with bowel cancer, because intensive chemotherapy causes a high rate of side effects.

This study compares a gentle chemotherapy treatment (capecitabine chemotherapy tablets given
by mouth) with the combination of capecitabine and bevacizumab and the combination of
capecitabine, bevacizumab and intravenous mitomycin C.

It is expected that a gentle chemotherapy treatment or a gentle chemotherapy treatment
combined with bevacizumab would be an appropriate treatment for both young and fit patients
as well as older and less fit patients who would not easily tolerate intensive chemotherapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00294359
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Niall C Tebbutt, BA (Hons) BM BCh PhD MRCP FRAC
Address 0 0
Ludwig Oncology Unit, Austin Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00294359