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Study 13 of 929 for search of: | Australia, Victoria |
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Sponsored by: |
Australasian Gastro-Intestinal Trials Group |
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Information provided by: | Australasian Gastro-Intestinal Trials Group |
ClinicalTrials.gov Identifier: | NCT00294359 |
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 |
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Metastatic Colorectal Cancer |
Drug: Mitomycin C; Capecitabine; Bevacizumab |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 333 |
Study Start Date: | June 2005 |
Study Completion Date: | July 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, New South Wales | |
Bankstown Hospital | |
Sydney, New South Wales, Australia | |
Campbelltown Hospital | |
Sydney, New South Wales, Australia | |
Lismore Hospital | |
Lismore, New South Wales, Australia | |
Liverpool Hospital | |
Sydney, New South Wales, Australia | |
Royal North Shore Hosp | |
Sydney, New South Wales, Australia | |
Newcastle Mater Hospital | |
Newcastle, New South Wales, Australia | |
North Shore Private Hospital | |
Sydney, New South Wales, Australia | |
Prince of Wales Hospital | |
Sydney, New South Wales, Australia | |
Nepean Hospital | |
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 | |
Tamworth Base Hospital | |
Tamworth, New South Wales, Australia | |
Westmead Hospital | |
Sydney, New South Wales, Australia | |
Southern Medical Daycare | |
Wollongong, New South Wales, Australia | |
St George Hospital | |
Sydney, New South Wales, Australia | |
Tweed Heads Hospital | |
Tweed Heads, 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 | |
Austin Health | |
Melbourne, Victoria, Australia | |
Bendigo Public Hospital | |
Bendigo, Victoria, Australia | |
Geelong Hospital | |
Geelong, Victoria, Australia | |
Box Hill Hospital | |
Melbourne, Victoria, Australia | |
Frankston Hospital | |
Melbourne, Victoria, Australia | |
Border Medical Oncology | |
Wodonga, Victoria, Australia | |
Monash Medical Centre | |
Melbourne, Victoria, Australia | |
Peter MacCallum Cancer Institute | |
Melbourne, Victoria, Australia | |
St Vincent's Hospital | |
Melbourne, 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 |
Principal Investigator: | Niall C Tebbutt, BA (Hons) BM BCh PhD MRCP FRAC | Ludwig Oncology Unit, Austin Health |
Study ID Numbers: | AG0501CR |
Study First Received: | February 21, 2006 |
Last Updated: | August 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00294359 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
colorectal neoplasm |
Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Bevacizumab Intestinal Diseases Rectal Diseases |
Mitomycins Intestinal Neoplasms Digestive System Diseases Mitomycin Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors |