TRIALS IN FOLLOW UP

The clinical trials listed in this section are closed to new patient recruitment. For each trial, an overview of the study design is provided together with a brief explanation of the trial objectives. A more detailed overview is available in the Members Area.

1. Oesophago-Gastric Cancer | ATTAX (AG0603G)
2. Colorectal Cancer | NCIC CO.17
3. Colon Cancer | NSABP CO6
4. Stage 11 & 111 Colon Cancer | NSABP CO7
5. Advanced GIST | AG0102 GIST / EORTC 62005
6. Liver Metastases (Colorectal) | EORTC 40983
7. Biliary Tract Cancer | ABC Trial (AG0403BT)
8. Oesophago-Gastric Cancer | ATTAX 2 (AG0603G EXT)
9. Metastatic Colorectal Cancer | MAX (AG0501CR)
10. Metastatic Colorectal Cancer | DaVINCI (AG0103CR)
11. Pancreas Cancer | GOFURTGO Trial (AG0503P)
12. European Study of Adjuvant Chemotherapies in Resectable Pancreatic Cancer (ESPAC) 3
13. Adjuvant GIST | EORTC 62024

1.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

2.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

3.Colon Cancer | NSABP CO6 - Click for Trial Schema

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.

Principal Investigators
Professor Michael Findlay Medical Oncologist Auckland Hospital, NZ

Supported by
National Surgical Adjuvant Breast and Bowel Project Inc. (USA)

4.Stage 11 & 111 Colon Cancer | NSABP CO7 - Click for Trial Schema

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.

Principal Investigators
Professor Michael Findlay Medical Oncologist Auckland Hospital, NZ

Supported by
National Surgical Adjuvant Breast and Bowel Project Inc. (USA), Sanofi-Aventis Inc. (USA) and Sanofi-Aventis Australia P/L

5.Advanced GIST | AG0102 GIST / EORTC 62005 - Click for Trial Schema

Phase III randomised, multi-centre, international trial to determine the relation between dose and clinical activity of STI—571 in patients with unresectable or metastatic malignant gastrointestinal stromal tumors expressing the c—kit receptor tyrosine kinase (CD117).

Gastro—intestinal stromal tumours (GIST) are rare and highly resistant to standard chemotherapy and radiation. A new chemotherapy tablet called STI—571 (Glivec®) has produced dramatic responses in people with this kind of cancer. This trial is comparing higher and lower doses of STI—571 to see which works best. Trials of STI—571 in other cancers are being planned around the world.

Principal Investigators
Professor John Zalcberg Medical Oncologist Peter MacCallum Cancer Centre, VIC

Supported by
Novartis Pharmaceuticals Australia P/L, Novartis International AG (Switzerland) and European Organisation for Research and Treatment of Cancer (Belgium)

6.Liver Metastases (Colorectal) | EORTC 40983 - Click for Trial Schema

Pre- and post-operative chemotherapy with oxaliplatin 5-FU/LV versus surgery alone in resectable liver metastases from colorectal origin - phase III study.

Cancers from the colon or rectum often spread to the liver (metastases). Sometimes these cancers can be removed from the liver with an operation, but the cancer often comes back later (recurs). This trial will determine if adding chemotherapy for three months before and after surgery can improve the cure and recurrence rates.

Principal Investigators
Doctor Euan Walpole Medical Oncologist Princess Alexandra Hospital, QLD

Supported by
European Organisation for Research and Treatment of Cancer (Belgium)

7.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

8.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

9.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

10.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

11.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

12.European Study of Adjuvant Chemotherapies in Resectable Pancreatic Cancer (ESPAC) 3 - Click for Trial Schema

Phase III adjuvant trial in pancreatic cancer comparing: 5-fluorouracil + D-L folinic acid with gemcitabine or no adjuvant treatment.

Surgery is the best treatment for cancers of the pancreas that have not spread further. However, despite the best surgery, the cancer often comes back (recurs). This trial will determine if chemotherapy given after surgery can prevent or delay cancer recurrence and its effects on quality of life.

Principal Investigators
Doctor Rob Padbury Hepatobiliary Surgeon Flinders Medical Centre, SA
Conjoint Professor David Goldstein Medical Oncologist Prince of Wales Hospital, NSW

Supported by
National Health and Medical Research Council (Australia) via the University of Sydney
Cancer Council New South Wales
Cancer Council Queensland
Cancer Council South Australia
Cancer Council Victoria

13.Adjuvant GIST | EORTC 62024 - Click for Trial Schema

Intermediate and high-risk localised, completely resected, gastro-intestinal stromal tumours (GIST) expressing c-kit receptor: A controlled randomised trial on adjuvant imatinib mesylate (Glivec®) versus no further therapy after completing surgery.

Imatinib mesylate is highly effective in advanced, unresectable GIST. However, the long-term effect of this agent on survival outcomes remains unclear. This study will compare the effect of adjuvant imatinib mesylate versus observation only on the prognosis of patients with completely resected localised gastrointestinal stromal tumours at intermediate- or high-risk of relapse.

Principal Investigators
Doctor Dusan Kotasek Medical Oncologist Ashford Cancer Centre, SA

Supported by
Novartis Pharmaceuticals Australia P/L