Clinical trials

A clinical trials cancer research program in the ACT
Principal Investigators: Dr D Yip, Dr P Craft, A/Prof R Stuart-Harris, Dr D Leong, Dr A Davis, The
Canberra Hospital
Grant Awarded: 2005-06, $33,700
The Canberra Hospital Medical Oncology Unit has continued clinical trial activities with the supportof The Cancer Council ACT. Four Clinical Trial Coordinators are currently employed by the Unit tocollect data and look after patients who enrol onto the studies. Funding is obtained throughsponsorships from pharmaceutical companies for commercial studies, charitable donations andresearch grants; but not through the hospital. The department has formed links with a number ofnational collaborative research groups for the conduct of multicentre studies. These groups include:the Australasian Gastrointestinal Trials Group (AGITG), Australian and New Zealand GynaecologicalOncology Group (ANZGOG), the Australian and New Zealand Breast Cancer Study Group(ANZBCSG) and the Australian Lung Trials Group (ALTG).
The results of important studies that The Canberra Hospital has contributed to over the last 5 yearshave led to expanded indications for the following oncology drugs: oxaliplatin (Eloxatin), letrozole(Femara), docetaxel (Taxotere) and trastuzumab (Herceptin). Further trials conducted here have ledto the registration of new drugs such as zoledronate (Zometa), pemetrexed (Alimta), erlotinib(Tarceva), sorafenib and sunitinib (Stutent). Patients participating on these clinical trials havebenefited through early access to these agents prior to licensing. The wider availability of thesedrugs has made significant improvements to survival and quality of life of cancer sufferers.
The following is a list of current studies or studies in follow-up conducted at the Canberra Hospitalthat are supported in part by TCCACT grant: Current studies:
A feasibility study of patient-initiated outpatient management of febrile neutropenia.
ESPAC –3: Phase III trial comparing 5FU and folinic acid versus gemcitabine in patients withresected pancreatic cancer.
SOFT: A Phase III trial evaluating the role of ovarian function suppression and the role ofexemestane as adjuvant therapies for pre-menopausal women with endocrine responsive breastcancer.
Studies in follow-up:
ANZGOG 02 01: A phase II trial of weekly docetaxel (Taxotere) for patients with relapsed ovariancancer who have previously received paclitaxel.
BIG 1-98: Randomised double blind phase III study of letrozole versus tamoxifen as adjuvantendocrine therapy in postmenopausal women with receptor positive breast cancer.
BIG2-98: Docetaxel sequentially or in combination with doxorubicin, followed by CMF(cyclophosphamide methotrexate and 5-fluorouracil), compared with doxorubicin alone or incombination with cyclophosphamide, followed by CMF, in the adjuvant treatment of node-positivebreast cancer patients BCIRG 005: A multicentre phase III randomized trial comparing docetaxel in combination withdoxorubicin and cyclophosphamide (TAC) versus doxorubicin and cyclophosphamide followed bydocetaxel (AC->T) as adjuvant treatment of operable breast cancer Her2neu negative patients withpositive axillary lymph nodes.
BCIRG 006: Multicentre phase III randomized trial comparing doxorubicin and cyclophosphamidefollowed by docetaxel (AC->T) with doxorubicin and cyclophosphamide followed by docetaxel andtrastuximab (AC->TH) and with docetaxel, platinum salt and trastuzumab (TCH) in the adjuvanttreatment of node positive and high risk node negative patients with operable breast cancercontaining the Her2neu alteration.
CO.17: Phase III randomised study of cetuximab (Erbutix, C225) and best supportive care versusbest supportive care in patients with pretreated metastatic epidermal growth factor receptor(EGFR)-positive colorectal carcinoma.
GOG0201: Phase II trial of weekly docetaxel (Taxotere) for patients with relapsed ovarian cancerwho have previously received paclitaxel VINCAP: Phase II Study of intravenous vinorelbine (Navelbine) + capecitabine (Xeloda) in patientswith advanced breast cancer.
ZEST: A double blind controlled trial of Zoloft’s effects on symptoms and survival time in advancedcancer.
A full list of currently open clinical trials, research publications and activities are listed at this websitehttp://health.act.gov.au/oncology under Medical Oncology Research.

Source: http://www.actcancer.org/downloads/File/Clinical%20trials.pdf