Status:
COMPLETED
The MAX Study: Mitomycin C, Avastin and Xeloda in Patients With Untreated Metastatic Colorectal Cancer
Lead Sponsor:
Australasian Gastro-Intestinal Trials Group
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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...
Detailed Description
Aims - The phase II stage of the study aims to determine the relative toxicity of the combination of capecitabine and bevacizumab and the combination of capecitabine, mitomycin C (MMC) and bevacizumab...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
333 Patients enrolled
Trial Details
Trial ID
NCT00294359
Start Date
June 1 2005
End Date
July 1 2007
Last Update
August 22 2007
Active Locations (36)
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1
Lismore Hospital
Lismore, New South Wales, Australia
2
Newcastle Mater Hospital
Newcastle, New South Wales, Australia
3
Bankstown Hospital
Sydney, New South Wales, Australia
4
Campbelltown Hospital
Sydney, New South Wales, Australia