Completed trials

The clinical trials listed in this section have been completed.

1.  Rectal Cancer | TROG/AGITG 01.04
2.  Advanced Gastric Cancer | AG9801
3.  Gastric Cancer (Operable) | AG9601
4.  Hepatocellular Cancer | AG0001H
5.  Metastatic Colorectal Cancer | AG9401
6.  Gastric/Lower Oesophageal Cancer | MAGIC: ST02
7.  Metastatic Pancreas Cancer | NCIC PA.3
8.  Oesophagus Cancer | IG9401
9.  Oesophago-Gastric Cancer | ATTAX (AG0603G)
10. Colorectal Cancer | NCIC CO.17
11. Biliary Tract Cancer | ABC Trial (AG0403BT)
12. Oesophago-Gastric Cancer | ATTAX 2 (AG0603G EXT)
13. Metastatic Colorectal Cancer | MAX (AG0501CR)
14. Metastatic Colorectal Cancer | DaVINCI (AG0103CR)
15. Pancreas Cancer | GOFURTGO Trial (AG0503P)
16. Oesophago-Gastric Cancer | ATTAX 3
17. Pancreas Cancer | LAP07
18. Metastatic Colorectal Cancer | CO.20
19. Colon Cancer | NSABP CO6
20. Stage 11 & 111 Colon Cancer | NSABP CO7
21. Adjuvant Colorectal Cancer | QUASAR 2 
22. Liver Metastases (Colorectal) | EORTC 40983
23. Pancreatic Cancer (ESPAC) 3
24. Gallbladder | TACTIC
25. Gastrointestinal Stromal Cancer | REGISTER
26. Pancreas | PAN-1
27. Pancreatic cancer | IMPACT
28. Oesophagus Cancer | DECO
29. Colorectal Cancer | SUPER
30. Colorectal Cancer | ATTACHE
31. Oesophago-Gastric Cancer | INTEGRATE

 

1. Rectal Cancer | TROG/AGITG 01.04

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

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

TROG/AGITG 01.04 schema 

2. Advanced Gastric Cancer | AG9801

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)

AG9801 schema

3. Gastric Cancer (Operable) | AG9601

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)

AG9601 schema

4. Hepatocellular Cancer | AG0001H

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

AG0001H schema

5. Metastatic Colorectal Cancer | AG9401

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 Investigator
Professor Stephen Ackland, Medical Oncologist Newcastle Mater Misericordiae Hospital NSW.

Supported by
The Cancer Council NSW

AG9401 schema

6. Gastric/Lower Oesophageal Cancer | MAGIC: ST02

A randomised, controlled trial of pre- and post-operative chemotherapy in patients with operable gastric and lower oesophageal 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 Investigator
Professor Michael Findlay, Medical Oncologist Auckland Hospital NZ.

MAGIC: ST02

7. Metastatic Pancreas Cancer | NCIC PA.3

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 Investigator
Associate Professor David Goldstein, Medical Oncologist Prince of Wales Hospital NSW.

Supported by
OSI Pharmaceuticals Inc. (USA)

NCIC PA.3 schema

8. Oesophagus Cancer | IG9401

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 Investigator
Associate Professor Bryan Burmeister, Radiation Oncologist Princess Alexandra Hospital QLD.

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

IG9401 schema

9. Oesophago-Gastric Cancer | ATTAX (AG0603G)

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 Investigator
Doctor Niall Tebbutt, Medical Oncologist Austin Health VIC.

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

ATTAX (AG0603G) schema

10. Colorectal Cancer | NCIC CO.17

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 Investigator
A/Prof Chris Karapetis, Medical Oncologist Flinders Medical Centre SA.

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

NCIC CO.17 schema

11. Biliary Tract Cancer | ABC Trial (AG0403BT)

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

ABC Trial (AG0403BT) schema

12. Oesophago-Gastric Cancer | ATTAX 2 (AG0603G EXT)

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 Investigator
Doctor Niall Tebbutt, Medical Oncologist Austin Health VIC.

Supported by
Alphapharm P/L

ATTAX 2 (AG0603G EXT) schema

13. Metastatic Colorectal Cancer | MAX (AG0501CR)

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 Investigator
Doctor Niall Tebbutt, Medical Oncologist Austin Health VIC.

Supported by
Roche Products P/L

MAX (AG0501CR) schema

14. Metastatic Colorectal Cancer | DaVINCI (AG0103CR)

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 Investigator
Professor Stephen Clarke, Medical Oncologist Concord Hospital NSW.

Supported by
Pfizer Australia P/L

DaVINCI (AG0103CR) schema

15. Pancreas Cancer | GOFURTGO Trial (AG0503P)

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

GOFURTGO Trial (AG0503P) schema

16. Oesophago-Gastric Cancer | ATTAX 3
A randomised phase II study  evaluating weekly docetaxel, cisplatin, fluoropyrimidine (wTCF) plus or minus panitumumab in advanced oesophago-gastric cancer.

Most cases of oesophageal and gastric cancer are locally advanced or metastatic at presentation.  Chemotherapy prolongs survival and improves the quality of life of patients, but standard chemotherapy for this disease is as yet undefined. The aim of this study is to evaluate the response rates of wTCF/X given with or without panitumumab in the treatment of patients with metastatic or locally recurrent oesophago-gastric cancer. The secondary objectives are to assess overall survival, progression-free survival, treatment related toxicity, disease associated symptoms and quality of life during treatment.

Study Chair: Associate Professor Niall Tebbutt

17. Pancreas Cancer | LAP07

Randomised multicentre phase III study in patients with locally advanced adenocarcinoma of the pancreas: gemcitabine with or without chemoradiotherapy and with or without erlotinib.  Adenocarcinoma of the pancreas represents 2% of all cancers and 10 % of gastrointestinal cancers.  Approximately 15-20% of patients presents with early disease and are able to undergo curative resection. Forty percent present with advanced loco regional disease precluding complete resection with a median survival time of 9 – 12 months. The available therapeutic options for patients with locally advanced pancreatic cancer (LAP) are systemic chemotherapy (CT) or chemoradiotherapy (CRT) but the choice of one or other of these regimens remains controversial with conflicting results reported in the literature. The identification of an effective treatment that can achieve durable symptom control remains a high priority for these patients. This study will examine many of the key clinical questions for patients with LA pancreatic cancer. It will test whether the addition of radiotherapy to standard chemotherapy will increase survival. The primary aim of this study is to determine the role of radiotherapy in patients with locally advanced pancreatic cancer. Secondary aims are to evaluate the efficacy and safety of erlotinib.

Study Chairs: Conjoint Clinical Professor David Goldstein and Dr Jenny Shannon

18. Metastatic Colorectal Cancer | CO.20
A phase III randomized study of Brivanib alaninate (BMS-582664) in combination with Cetuximab (Erbitux®) versus placebo in combination with Cetuximab (Erbitux®) in patients with K-Ras Wild Type tumours previously treated with combination chemotherapy for metastatic colorectal carcinoma.

CO.20 will examine the effect of cetuximab and brivanib (BMS-582664) versus cetuximab alone on overall survival and quality of life in patients with advanced colorectal cancer (K-Ras Wild Type Tumours) who have failed all chemotherapy (including a thymidylate synthase inhibitor, an irinotecan-containing regimen and an oxaliplatin-containing regimen) recommended by their oncologist, and for whom no standard anticancer therapy other than cetuximab is available. Additional assessments will include putative predictive molecular markers, health utility and economic evaluation.

Study Chair: Dr Jeremy Shapiro

19. Colon Cancer | NSABP CO6
A clinical trial comparing 5-Fluoroucil (5-FU) plus leucovorin (LV) and UFT plus LV for the treatment of patients with stages II and III carcinoma of the colon.

Adjuvant chemotherapy with 5-FU and LV given after surgery improves recurrence and cure rates for people with early colon cancer. Most chemotherapy is given through a tube into the vein (intra-venous infusion). UFT is a new chemotherapy drug that is given as a tablet; its effects on the cancer are similar to 5-FU. This study will determine if using UFT instead of 5-FU will result in people living as long and with better quality of life.

 Study Chair: Professor Michael Findlay

20. Stage 11 & 111 Colon Cancer | NSABP CO7
A clinical trial comparing 5-Fluorouracil (5-FU) plus leucovorin (LV) and oxaliplatin with 5-FU plus LV for the treatment of patients with stages II and III carcinoma of the colon.

Adjuvant chemotherapy with 5-FU and LV given after surgery improves recurrence and cure rates for people with early colon cancer. Oxaliplatin is a chemotherapy drug that can help people with advanced colon cancer. This study will determine if adding oxaliplatin to standard treatment can also help people with early colon cancer.

Study Chair: Professor Michael Findlay

21. Adjuvant Colorectal Cancer | QUASAR 2
Multicentre international study of capecitabine +/- bevacizumab as adjuvant treatment of colorectal cancer.

QUASAR2 uses a new combination for adjuvant therapy: an oral chemotherapy drug (capecitabine) and a molecularly targeted therapy (bevacizumab), to define whether this is superior in efficacy and less in toxicity than capecitabine alone.

Study Chair: A/Professor Eva Segelov

22. Liver Metastases (Colorectal) | EORTC 40983
Pre- and post-operative chemotherapy with oxaliplatin 5-FU/LV versus surgery alone in resectable liver metastases from colorectal origin – phase III study.

23. Pancreatic Cancer | ESPAC 3
European Study of Adjuvant Chemotherapies in Resectable Pancreatic Cancer (ESPAC-3 Study)

24. Gallbladder | TACTIC
Phase II trial of gemcitabine, cisplatin and panitumumab in biliary tract cancer.

This is a phase II, multicentre, open-label, single arm study looking at the role of panitumumab in combination with gemcitabine and cisplatin in KRAS wild-type patients with metastatic, inoperable or recurrent biliary tract carcinoma (BTC). The primary objective of this study is to determine the objective clinical benefit of panitumumab in combination with gemcitabine and cisplatin in biliary tract cancer. The secondary objectives are to assess the tolerability and safety of the study treatment, overall survival, progression free survival, time to treatment failure, quality of life and tissue biomarkers of participating patients.

Study Chair: Dr Jenny Shannon

25. Gastrointestinal Stromal Cancer | REGISTER
A multicentre phase II study of risk. Evaluation in GIST with selective therapy escalation for response.

To evaluate the time to ultimate disease progression on study treatment of patients with exon 9/ wild type (WT) GIST treated using a risk stratification and sequential dose escalation strategy of imatinib followed by nilotinib, in comparison with historical controls.

Study Chair: Dr Jayesh Desai

26. Pancreas | PAN-1
A Randomised Phase II Study Evaluating Potential Predictive
Biomarkers in the Treatment of Locally Advanced and Metastatic Pancreatic Cancer

To prospectively evaluate hENT1 as a predictive marker of benefit from gemcitabine treatment in locally advanced and metastatic pancreatic cancer.

Study Chair: Dr Yu Jo Chua

27. Pancreatic cancer | IMPACT
Individualised Molecular Pancreatic Cancer Therapy (IMPACT): A randomised, open label, phase II trial assessing standard first line treatment with gemcitabine or personalised treatment based on tumour molecular signature in patients with recurrent or metastatic pancreatic cancer to evaluate feasibility and impact on progression free survival.

A phase II trial assessing feasibility of personalised treatment based on tumour molecular signature in patients with recurrent or metastatic pancreatic cancer.

Study Chair: Prof Andrew Biankin

28. Oesophagus Cancer | DECO
A randomised phase II trial of weekly docetaxel (Taxotere®) chemoradiotherapy +/- cetuximab (Erbitux®) in the treatment of localised resectable cancer of the DECO

29. Colorectal Cancer | SUPER
A randomised phase III multicentre study evaluating the role of palliative surgical resection of the primary tumour in patients with metastatic colorectal cancer.

Study Chairs: Professor Cameron Platell & Associate Professor Niall Tebbutt

30. Colorectal Cancer | ATTACHE A Trial in the timing of Surgery and Adjuvant Chemotherapy for  Hepatic Metastases from Colorectal Cancer.

Study Chairs: Professor Jonathan Fawcett & Professor David Goldstein

31. Oesophago-Gastric Cancer | INTEGRATE A randomised phase II double-blind placebo-controlled study of regorafenib in refractory Advanced Oesophago-Gastric Cancer.

Study Chair:  A/Prof. Nick Pavlakis

Donate Now