COMPLETED TRIALS

The clinical trials listed in this section have been completed.

Rectal Cancer | TROG/AGITG 01.04
Advanced Gastric Cancer | AG9801
Gastric Cancer (Operable) | AG9601
Hepatocellular Cancer | AG0001H
Metastatic Colorectal Cancer | AG9401
Gastric/Lower Oesophageal Cancer | MAGIC: ST02
Metastatic Pancreas Cancer | NCIC PA.3
Oesophagus Cancer | IG9401
Oesophago-Gastric Cancer | ATTAX (AG0603G)
Colorectal Cancer | NCIC CO.17
Biliary Tract Cancer | ABC Trial (AG0403BT)
Oesophago-Gastric Cancer | ATTAX 2 (AG0603G EXT)
Metastatic Colorectal Cancer | MAX (AG0501CR)
Metastatic Colorectal Cancer | DaVINCI (AG0103CR)
Pancreas Cancer | GOFURTGO Trial (AG0503P)

1.Rectal Cancer | TROG/AGITG 01.04 - Click for Trial Schema

A randomised trial of preoperative radiotherapy for stage T3 Adenocarcinoma of rectum.

Principal Investigators
Associate Professor Sam Ngan Division of Radiation Oncology Peter MacCallum Cancer Centre VIC Australia.

2.Advanced Gastric Cancer | AG9801 - Click for Trial Schema

A phase II study of irinotecan, leucovorin and 5-fluorouracil in advanced gastric cancer.

This trial was designed to assess the efficacy and toxicity of irinotecan, leucovorin, and 5-flourouracil for patients with advanced gastric cancer.

Principal Investigators
Professor Stephen Ackland Medical Oncologist Newcastle Mater Misericordiae Hospital, NSW
Doctor David Storey Upper GI Surgeon Royal Prince Alfred Hospital, NSW

Supported by
Pharmacia P/L (Australia)

3.Gastric Cancer (Operable) | AG9601 - Click for Trial Schema

A phase II feasibility study of pre-operative and post-operative chemotherapy using epirubicin, cisplatin and protracted venous infusion fluorouracil (ECF) in patients with advanced but operable gastric cancer.

Surgery is the standard treatment for cancers of the stomach (gastric) and lower oesophagus (gullet) that can be removed with an operation, but the cancer often comes back (recurs) despite the best surgery. This trial will determine if adding chemotherapy two months before and two months after surgery improves recurrence and cure rates.

Principal Investigators
Professor Michael Findlay Medical Oncologist Auckland Hospital, NZ
Doctor David Storey Upper GI Surgeon Royal Prince Alfred Hospital, NSW

Supported by
Pharmacia Australia P/L
NHMRC Clinical Trials Centre (Australia)

4.Hepatocellular Cancer | AG0001H - Click for Trial Schema

Pilot phase II study of Sandostatin LAR® in patients with advanced hepatocellular carcinoma.

Advanced hepatocellular carcinoma is a disease with minimal effective treatment options available and a very poor prognosis. This study hopes to determine the feasibility of delivering a treatment that has produced encouraging results in another small randomised study. The study determines whether treating people with Sandostatin LAR® means that they live longer and feel better. The study will also tell us whether the treatment has any impact on tumour growth and to see if the effect of Sandostatin LAR® on tumour growth is different when the tumour has somatostatin receptors. These results will help to decide whether or not to continue investigating this treatment in larger randomised studies.

Principal Investigators
Associate Professor Jonathon Cebon Medical Oncologist Austin Health, VIC
Professor Michael Findlay Medical Oncologist Auckland Hospital, NZ

Supported by
Novartis Pharmaceuticals Australia P/L

5.Metastatic Colorectal Cancer | AG9401 - Click for Trial Schema

A randomised trial of early chemotherapy in asymptomatic metastatic colorectal cancer.

People with advanced colon cancer sometimes feel completely well when they are first diagnosed. This study asks the question, “Is it better to start chemotherapy immediately - causing serious side-effects - or delay until symptoms appear?” The results of this study demonstrated that delaying chemotherapy was as safe as giving treatment straightaway and allowed better quality of life in the meantime.

Principal Investigators
Professor Stephen Ackland Medical Oncologist Newcastle Mater Misericordiae Hospital, NSW

Supported by
The Cancer Council NSW

6.Gastric/Lower Oesophageal Cancer | MAGIC: ST02 - Click for Trial Schema

A Randomised, Controlled Trial of Pre- and Post-Operative Chemotherapy in Patients with Operable Gastric and Lower Oesophageal Cancer.

Principal Investigators
Professor Michael Findlay Medical Oncologist Auckland Hospital, NZ

7.Metastatic Pancreas Cancer | NCIC PA.3 - Click for Trial Schema

A randomised placebo controlled study of OSI-774 (Tarceva™) plus gemcitabine in patients with locally advanced, unresectable or metastatic pancreatic cancer.

When cancers of the pancreas are detected they have often spread to other parts of the body (metastases), or they return (recur) after surgery. The best treatment in this situation is chemotherapy with a drug called gemcitabine. As a result of chemotherapy, in many cases, the cancer will stop growing or get smaller for a time. In spite of chemotherapy, many of the cancers will start growing or return after a period of time. This trial will determine if a new drug, OSI-774 (Tarceva™) given with chemotherapy will result in people living longer and with better quality of life.

Principal Investigators
Associate Professor David Goldstein Medical Oncologist Prince of Wales Hospital, NSW

Supported by
OSI Pharmaceuticals Inc. (USA)

8.Oesophagus Cancer | IG9401 - Click for Trial Schema

A randomised phase III clinical trial comparing surgery alone with concurrent pre-operative chemotherapy and radiation followed by surgery alone for resectable carcinoma of the oesophagus.

Surgery is the standard treatment for cancers of the oesophagus (gullet). However, the cancer often comes back (recurs) despite the best surgery. This trial will determine if adding chemotherapy and radiation therapy before surgery improves recurrence and cure rates.

Principal Investigators
Associate Professor Bryan Burmeister Radiation Oncologist Princess Alexandra Hospital, QLD

Supported by
Funded for the first three years by NHMRC (Australia)

9.Oesophago-Gastric Cancer | ATTAX (AG0603G) - Click for Trial Schema

A randomised phase II study evaluating a weekly schedule of docetaxel with cisplatin and 5-FU (wTCF) or with capecitabine (wTX) in advanced oesophago-gastric cancer.

In Australia and New Zealand, there are approximately 3,485 new cases diagnosed and 2,741 deaths annually from oesophageal and gastric cancers. Therapeutic options for patients with advanced oesophageal and gastric cancer include chemotherapy, but current treatments need to be improved upon. This study is assessing the effectiveness of two different combinations of chemotherapy on the growth of tumours and the undesirable side-effects of the treatments. This study will help to decide which treatments are most promising and should be compared with current treatments in the future in an effort to improve the time people live after a diagnosis of oesophageal or gastric cancer.

Principal Investigators
Doctor Niall Tebbutt Medical Oncologist Austin Health, VIC

Supported by
Aventis Pharma P/L and Roche Products P/L

10.Colorectal Cancer | NCIC CO.17 - Click for Trial Schema

A phase III randomised study of cetuximab (ERBITUX™, C225) and best supportive care versus best supportive care in patients with pre-treated metastatic epidermal growth factor receptor (EGFR) positive colorectal carcinoma.

Therapeutic options for patients with metastatic colorectal cancer whose cancers have progressed after treatment with standard therapies are limited. Cetuximab therapy is a new treatment targeting the epidermal growth factor receptor (EGFR, a protein on the surface of many cancer cells). Cetuximab can attach to this protein and may stop cancer growth. This study will examine the effect of cetuximab on length and quality of life in people with advanced EGFR positive colorectal cancer whose cancer has progressed after chemotherapy.

Principal Investigators
Doctor Chris Karapetis Medical Oncologist Flinders Medical Centre, SA

Supported by
Bristol-Myers Squibb Company (USA) National Cancer Institute of Canada Clinical Trials Group

11.Biliary Tract Cancer | ABC Trial (AG0403BT) - Click for Trial Schema

A phase II trial of gemcitabine in fixed rate dose infusion combined with cisplatin in patients with inoperable biliary tract carcinomas.

Biliary tract cancers are uncommon; as a result it is not a well-studied disease and treatment options for this condition are limited. This study will assess the impact of a new combination of chemotherapy drugs on the growth of the cancer and the undesirable side-effects of treatment.

Principal Investigators
Conjoint Professor David Goldstein Medical Oncologist Prince of Wales Hospital, NSW
Doctor Jenny Shannon Medical Oncologist Nepean Hospital, NSW

Supported by
Eli Lilly Australia P/L

12.Oesophago-Gastric Cancer | ATTAX 2 (AG0603G EXT) - Click for Trial Schema

Phase II study of cetuximab (Erbitux™) plus weekly docetaxel chemotherapy in docetaxel refractory patients with EGFR positive advanced oesophago-gastric cancer.

Most cases of oesophageal and gastric cancer are locally advanced or metastatic at presentation. Chemotherapy prolongs survival and improves quality of life in such patients, but standard chemotherapy for this disease has not been defined.

ATTAX 2 is an optional extension study for patients who have participated in the ATTAX study (AG0603) (all of whom receive docetaxel) and who have progressed either during or within six months of chemotherapy. The primary objective is to evaluate the response rate of cetuximab plus docetaxel in patients with docetaxel refractory advanced oesophago-gastric cancer. Secondary objectives include assessment of cetuximab plus docetaxel toxicity, progression free and overall survival, and improvements in symptom control.

Principal Investigators
Doctor Niall Tebbutt Medical Oncologist Austin Health, VIC

Supported by
Alphapharm P/L

13.Metastatic Colorectal Cancer | MAX (AG0501CR) - Click for Trial Schema

A randomised phase II/III study design to evaluate the role of Mitomycin C, Avastin and Xeloda in patients with metastatic colorectal cancer.

This is a phase II/III study evaluating the role of Mitomycin C (MMC), Avastin and Xeloda in metastatic colorectal cancer. The primary aim is to determine an optimal low toxicity regimen which could be used in a broad range of patients. Patients for whom fluoropyrimidine monotherapy is considered appropriate will be randomised to receive capecitabine, capecitabine plus bevacizumab or the combination of capecitabine, bevacizumab and MMC.

Principal Investigators
Doctor Niall Tebbutt Medical Oncologist Austin Health, VIC

Supported by
Roche Products P/L

14.Metastatic Colorectal Cancer | DaVINCI (AG0103CR) - Click for Trial Schema

Randomised phase III trial of De Gramont schedule 5-fluorouracil and leucovorin plus irinotecan versus single agent irinotecan in patients with previously treated metastatic colorectal cancer.

Single agent Irinotecan and Irinotecan/5FU/LV combinations are frequently used second line regimens for patients with metastatic colorectal cancer, but it is unknown which is superior.

This study originally planned to recruit 300 patients with the primary end-point being tumour response. However, due to slower than expected recruitment, an amendment was proposed in September 2006 to revise the sample size and study end-points

Diarrhoea is the principal toxicity associated with both the single agent and combination regimens; it would therefore be useful to directly compare both and demonstrate a clinically significant difference in the rates of diarrhoea; the principal treatment limiting toxicity.

A revised sample size of 150 patients will allow the comparison of rates diarrhoea and side effects of treatment and effect on patients quality of life. This study will look at patients’ response to treatment and their overall survival.

Principal Investigators
Professor Stephen Clarke Medical Oncologist Concord Hospital, NSW

Supported by
Pfizer Australia P/L

15.Pancreas Cancer | GOFURTGO Trial (AG0503P) - Click for Trial Schema

Phase II study of fixed dose rate gemcitabine-oxaliplatin integrated with concomitant 5-FU and 3-D conformal radiotherapy for the treatment of localised pancreatic cancer.

Many patients diagnosed with cancer of the pancreas present late with tumours that are already locally advanced and usually not removable by surgery. This phase II study will evaluate the activity and toxicity of chemoradiation after initial chemotherapy and before consolidation chemotherapy with gemcitabine and oxaliplatin. Based on the results achieved in this study, the AGITG aims to test the best regimen in a future phase III study comparing it with an accepted standard regimen.

Principal Investigators
Conjoint Professor David Goldstein Medical Oncologist Prince of Wales Hospital, NSW
Doctor Nigel Spry Radiation Oncologist Sir Charles Gairdner Hospital, WA

Supported by
Sanofi-Aventis Group Pty Limited (Australia)
NHMRC Clinical Trials Centre (Australia)
Cancer Council New South Wales
Cancer Council Western Australia