| Gastrointestinal cancer trials |
|
| Associate program managers: Kate Wilson, Reena Gill |
|
| Trials open to recruitment |
|
|
| Da Vinci: Phase II-III trial of irinotecan versus irinotecan + De Gramont schedule 5-fluorouracil and folinic acid in patients with previously treated metastatic colorectal cancer (AG103CR) |
| AGITG study
Participants
Patients with treated metastatic colorectal cancer
Treatment
• irinotecan + 5-flourouracil + leucovorin
• irinotecan
Outcome measures
• toxicity
• safety
• quality of life
• survival
Recruitment target: 100
Funding: Pfizer Australia
Status: open to recruitment
Recruitment target: 100 |
| Quasar 2: Phase III study of capecitabine and bevacizumab as adjuvant treatment of colorectal cancer |
Oxford Clinical Trials Office (OCTO)–AGITG study
Participants
Patients with colon cancer treated by surgery
Treatment
• capecitabine
• capecitabine + bevacizumab
Outcome measures
• disease-free survival
Recruitment target: 120
Funding: Roche Products (Australia)
Status: open to recruitment
Recruitment target: 120 |
| Phase III adjuvant trial in pancreatic cancer comparing: 5-fluorouracil + D-L folinic acid with gemcitabine or no adjuvant treatment (ESPAC-3) |
European Study Group for Pancreatic Cancer (ESPAC)–AGITG study
Participants
Patients who undergo surgery for pancreatic cancer
Treatment
5-fluorouracil + D-L folinic acid + surgery
gemcitabine
surgery
Outcome measures disease-free survival survival quality of life
Recruitment target: 990 (150 from Australia and New Zealand)
Funding: National Health and Medical Research Council (NHMRC)
Status: open to recruitment
Recruitment target: 150 |
| Gastrointestinal stromal tumors (GIST) expressing KIT receptor: adjuvant imatinib mesylate (Glivec) versus no further therapy after surgery (EORTC 62024) |
European Organisation for Research and Treatment of Cancer (EORTC)–AGITG study
Participants
Patients with operated gastrointestinal stromal tumour
Treatment
imatinib
Outcome measures
survival
relapse-free survival
relapse-free interval
Recruitment target: 990 (80 from Australia and New Zealand)
Funding: State cancer councils, Novartis Pharmaceuticals Australia, EORTC
Status: open to recruitment |
|
| |
Back to top |
| Pending trials |
| Phase III study of BMS-582664 with cetuximab versus placebo with cetuximab in patients previously treated with combination chemotherapy for metastatic colorectal carcinoma (CO.20) |
National Cancer Institute of Canada (NCIC)-AGITG study
Participants
Patients with advanced colorectal cancer
Treatment
• cetuximab and BMS-582664
• cetuximab and placebo
Outcome measures
• survival
• progression-free survival
• tumour response
• toxicity
• quality of life
Recruitment target: 370
Funding: Bristol-Myers Squibb and NCIC
Status
Open to recruitment in 2008 |
| ATTAX 3: Randomised phase II study evaluating weekly docetaxel, cisplatin, fluoropyrimidine plus or minus panitumumab in advanced oesophagogastric cancer |
AGITG study
Participants
Patients with advanced oesophagogastric cancer
Treatment
• weekly docetaxel, cisplatin, fluoropyrimidine
• weekly docetaxel, cisplatin, fluoropyrimidine and panitumumab
Outcome measures
• objective tumour response rate
• survival
• progression-free survival
• toxicity
• quality of life
• disease-associated symptoms
• tissue biomarkers
Recruitment target: 100
Status
Open to recruitment in 2009 |
| DECO: Randomised phase II trial of weekly docetaxel (Taxotere) chemoradiotherapy with or without cetuximab (Erbitux) in the treatment of localised resectable cancer of the oesophagus |
| AGITG study
Participants
Patients with resectable oesophageal cancer
Treatment
• docetaxel
• docetaxel + cetuximab
Outcome measures
• complete response rate
• disease-free survival
• survival
• toxicity
Recruitment target: 80
Funding: Merck Serono Australia
Status
Open to recruitment in 2008 |
| Resectable gastric study: Randomised phase III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for gastric cancer |
| Trans-Tasmanian Oncology Group (TROG)–AGITG study
Participants
Patients with resectable gastric cancer
Treatment
preoperative chemotherapy
preoperative chemo- radiotherapy
postoperative chemotherapy
no chemotherapy
Outcome measures
survival
disease-free survival
toxicity
response rate
complete resection rate
Recruitment target: 140
Status
Open to recruitment in 2008 |
| Register: Phase II study in adults with newly diagnosed gastrointestinal stromal tumour (GIST) incorporating risk-stratification and sequential dose-escalation of imatinib in patients with tumours containing an exon 9 mutation and subsequent addition of nilotinib in poor responders |
AGITG study
Participants
Adult patients with a new diagnosis of advanced GIST
Treatment
• imatinib
• nilotinib
Outcome measures
• progression-free survival
• toxicity
• pharmacodynamic markers
• efficacy of early nilotinib
• survival
Recruitment target: 100
Status
Open to recruitment in 2008 |
PETACC 6: Phase III randomised study of preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs capecitabine alone in rectal cancer |
European Organisation for Research and Treatment of Cancer (EORTC)–AGITG study
Participants
Patients with locally advanced rectal cancer
Treatment
preoperative capecitabine + radiotherapy, surgery, and postoperative capecitabine
preoperative capecitabine + radiotherapy + oxaliplatin, surgery, and postoperative capecitabine
Outcome measures
disease-free survival
survival
perioperative complications
toxicity
Recruitment target: 100
Funding: Cancer Australia
Status
Open to recruitment in 2008 |
|
| Back to top |
| Trials closed to recruitment |
| MAX: a randomised phase II-III study to evaluate the role of Mitomycin C [mitomycin], Avastin [bevacizumab] and Xeloda [capecitabine] in patients with untreated metastatic colorectal cancer (AG0501CR) |
Investigator-initiated intergroup trial: AGITG
Participants
Patients with previously untreated metastatic colorectal cancer for whom the investigator considers capecitabine monotherapy appropriate
Outcome measures
. treatment toxicity
. response rate
. progression-free survival
. overall survival
. quality of life
. cost-effectiveness
Recruitment: 471
Funding: Roche
Status: In follow-up |
EORTC 40983: Pre- and postoperative chemotherapy with oxaliplatin, 5-fluorouracil and leucovorin compared with surgery alone for resectable liver metastases of colorectal origin |
Investigator-initiated intergroup trial: AGITG and EORTC
Status: Open to recruitment
Participants
Patients with potentially resectable liver metastases from colorectal origin. Patients will not have received prior therapy for advanced disease.
Outcome measures
progression free survival
survival
Recruitment: 35
Funding: EORTC and AGITG
Status: In follow-up
|
ATTAX: Phase II study evaluating a weekly schedule of docetaxel with cisplatin and 5-fluorouracil or capecitabine (AG0603G) |
| AGITG study
Participants
Patients with inoperable biliary carcinomas advanced oesophageal of gastric cancer
Treatment
docetaxel, cisplatin, 5-fluorouracil
docetaxel, capecitabine
Outcome measures
• tumour response
Recruitment: 106
Funding: Sanofi Aventis (Australia) and Roche Products (Australia)
Status: In follow-up |
ABC: Phase II trial of gemcitabine in fixed-dose-rate infusion compared with cisplatin in patients with biliary tract carcinoma (AG0403BT) |
AGITG study
Participants
Patients with inoperable biliary carcinomas
Treatment
• gemcitabine
• cisplatin
Outcome measures
• tumour response
• safety
Recruitment: 50
Funding: Eli Lilly Australia and NHMRC Clinical Trials Centre
Status: In follow-up |
| Back to top |
| CO.17: Phase III study of cetuximab and best supportive care versus best supportive care in patients with pretreated metastatic epidermal-growth-factor-receptor (EGFR-positive colorectal carcinoma) |
National Cancer Institute of Canada (NCIC)-AGITG study
Participants
Patients with inoperable biliary carcinomas advanced oesophageal of gastric cancer
Treatment
cetuximab + supportive care
supportive care
Outcome measures
• survival
• time to progression
• tumour response
• quality of life
Recruitment: 252
Funding: Bristol-Myers Squibb and NCIC
Status: In follow-up |
ATTAX 2: Phase II study of cetuximab plus docetaxel in docetaxel-refractory patients with EGFR-positive cancer (AG0603G) |
AGITG study
Participants
Patients with inoperable biliary carcinomas advanced oesophageal of gastric cancer
Treatment
cetuximab + docetaxel
Outcome measures
• tumour response
Recruitment: 38
Funding: Alphapharm (Australia)
Status: In follow-up |
| Oral uracil/ftorfur plus leucovorin compared with 5-fluorouracil plus leucovorin in the treatment of patients with stages II and III carcinoma of the colon (C-06) |
Investigator-initiated intergroup trial: AGITG and NSABP
Status: closed to recruitment
Participants
Patients with stage II and stage III adenocarcinoma of the colon, no metastatic disease and a life expectancy of at least 10 years (excluding the diagnosis of cancer)
Outcome measures
disease-free survival
survival
quality of life
prognostic significance of genetic and biologic markers and their relationships with tumour characteristics
Recruitment: 11
Funding: NSABP and NCI |
5-fluorouracil plus leucovorin and oxaliplatin compared with 5-fluorouracil plus leucovorin for the treatment of patients with stages II and III carcinoma of the colon (C-07) |
Investigator-initiated intergroup trial: AGITG and NSABP
Status: closed to recruitment
Participants
Patients with stage II and III adenocarcinoma of the colon, no metastatic disease and a life expectancy of at least 10 years (excluding the diagnosis of cancer)
Outcome measures
survival
disease-free survival
Recruitment: 134
Funding: NSABP, NCI, Sanofi |
| Phase III randomised, intergroup, international trial assessing the clinical activity of STI-571 at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) expressing the KIT receptor tyrosine kinase (CD117) (EORTC 62005) |
European Organisation for Research and Treatment of Cancer (EORTC)–AGITG study
Participants
Patients with histologically documented diagnosis of unresectable and/or metastatic GIST, which is incurable with any conventional multimodality approach. Patients will have immunohistochemical documentation of c-kit (CD117) expression by tumour documented by DAKO antibody staining.
Outcome measures
progression-free survival
survival
objective tumour response
Status: closed
Recruitment target: 600
Funding: Novartis
Recruitment was extended by the EORTC to allow access to the trial for all patients with GIST. |
Gofurtgo: Phase II study of fixed-dose rate gemcitabine–oxaliplatin integrated with concomitant 5-fluorouracil and radiotherapy to treat localised pancreatic cancer (AG0503P) |
AGITG study
Participants
Patients with localised pancreastic cancer
Treatment
radiotherapy, gemcitabine, oxaliplatin
Outcome measures
• tumour response
• safety
Recruitment: 48
Funding: Sanofi-Aventis Group (Australia) and NHMRC Clinical Trials Centre
Status: In follow-up |
|
| Back to top |