The MAX Study: Mitomycin C, Avastin and Xeloda in Patients With Untreated Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Australasian Gastro-Intestinal Trials Group
• Treatments: Bevacizumab; Capecitabine; Mitomycin; Mitomycins

Criteria

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

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