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Trials > Cancer > Gastrointestinal cancer

Gastrointestinal cancer trials  
Associate program managers: Kate Wilson, Reena Gill
Pending trials | Closed trials
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


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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


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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

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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


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