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

This study has been completed.
Sponsor:
Information provided by:
Australasian Gastro-Intestinal Trials Group
ClinicalTrials.gov Identifier:
NCT00294359
First received: February 21, 2006
Last updated: August 21, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Mitomycin C; Capecitabine; Bevacizumab
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Australasian Gastro-Intestinal Trials Group:

Primary Outcome Measures:
  • Phase II: - treatment related toxicity
  • Phase III: - progression free survival

Secondary Outcome Measures:
  • Phase II: - treatment response
  • Phase III:
  • - treatment related toxicity
  • - treatment response
  • - overall survival
  • - symptoms of disease, treatment and quality of life
  • - cost of therapy and assessment of gain in quality-adjusted progression free survival

Estimated Enrollment: 333
Study Start Date: June 2005
Study Completion Date: July 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294359

Locations
Australia, New South Wales
Lismore Hospital
Lismore, New South Wales, Australia
Newcastle Mater Hospital
Newcastle, New South Wales, Australia
Bankstown Hospital
Sydney, New South Wales, Australia
Liverpool Hospital
Sydney, New South Wales, Australia
Nepean Hospital
Sydney, New South Wales, Australia
Campbelltown Hospital
Sydney, New South Wales, Australia
North Shore Private Hospital
Sydney, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
Royal North Shore Hosp
Sydney, New South Wales, Australia
Sydney Cancer Centre, Concord Repat General Hospital
Sydney, New South Wales, Australia
Sydney Cancer Centre, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
St George Hospital
Sydney, New South Wales, Australia
Tamworth Base Hospital
Tamworth, New South Wales, Australia
Tweed Heads Hospital
Tweed Heads, New South Wales, Australia
Southern Medical Daycare
Wollongong, New South Wales, Australia
Australia, Queensland
Royal Brisbane Hospital
Brisbane, Queensland, Australia
Australia, South Australia
Flinders Medical Centre
Adelaide, South Australia, Australia
Queen Elizabeth Hospital / Lyell McEwin Centre
Adelaide, South Australia, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia
Australia, Victoria
Bendigo Public Hospital
Bendigo, Victoria, Australia
Geelong Hospital
Geelong, Victoria, Australia
Frankston Hospital
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Austin Health
Melbourne, Victoria, Australia
Peter MacCallum Cancer Institute
Melbourne, Victoria, Australia
Box Hill Hospital
Melbourne, Victoria, Australia
St Vincent's Hospital
Melbourne, Victoria, Australia
Border Medical Oncology
Wodonga, Victoria, Australia
Australia, Western Australia
Fremantle Hospital
Perth, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
St John of God Hospital, Subiaco
Perth, Western Australia, Australia
New Zealand
Christchurch Hospital
Christchurch, New Zealand
Palmerston North Hospital
Palmerston, New Zealand
Sponsors and Collaborators
Australasian Gastro-Intestinal Trials Group
Investigators
Principal Investigator: Niall C Tebbutt, BA (Hons) BM BCh PhD MRCP FRAC Ludwig Oncology Unit, Austin Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00294359     History of Changes
Other Study ID Numbers: AG0501CR
Study First Received: February 21, 2006
Last Updated: August 21, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Australasian Gastro-Intestinal Trials Group:
colorectal neoplasm

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Mitomycins
Mitomycin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014