Randomised, double blind, placebo-controlled, multi-centre, group-sequential trial of G17DT for patients with advanced pancreatic cancer unsuitable or unwilling to take chemotherapy

Gilliam, Andrew D.; Topuzov, Eldar; Garin, A.; Pulay, I; Broome, P.; Watson, Susan A.; Takhar, Arjun; Beckingham, I. J.

doi:10.1200/jco.2004.22.14_suppl.2511

Cited by 21 publications

(10 citation statements)

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“…Indeed, another randomised placebo-controlled study was recently reported evaluating another gastrin-targeted strategy using G17DT, a gastrin immunogen inducing neutralising antibodies to gastrin. A borderline significant survival benefit was seen with G17DT compared to placebo (median survival 150 vs 83 days; Wilcoxon P ¼ 0.047), although there was a lower incidence of metastatic stage IV disease in the G17DT arm (73 vs 84%, respectively) (Gilliam et al, 2004). However, when G17DT was combined with gemcitabine in an RCT of 383 patients, the combination did not produce a survival advantage over gemcitabine alone (P ¼ 0.1) (Shapiro et al, 2005).…”

Section: Discussionmentioning

confidence: 97%

Gastrazole (JB95008), a novel CCK2/gastrin receptor antagonist, in the treatment of advanced pancreatic cancer: results from two randomised controlled trials

et al. 2006

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Gastrin has been shown to be a growth stimulant in pancreatic cancer cells. Gastrazole is a potent and selective gastrin receptor antagonist. Two randomised blinded trials were conducted to assess the effect of gastrazole in advanced pancreatic cancer. Patients with biopsy-proven, inoperable pancreatic carcinoma were recruited. Trial A compared protracted venous infusion (PVI) gastrazole with PVI placebo, whereas trial B compared PVI gastrazole with PVI fluorouracil (5-FU). Eighteen patients were randomised in trial A. Gastrazole produced significantly better survival compared to placebo (median 7.9 months vs 4.5 months; 1-year survival: 33 vs 11%, respectively; log rank P ¼ 0.02). No difference in toxicity was seen between gastrazole and placebo, except central venous catheter and pump complications. Ninety-eight patients were randomised in trial B. No significant survival difference was detected between gastrazole and 5-FU (median: 3.6 vs 4.2 months; 1-year survival: 13.2 vs 26.2%, respectively; log rank P ¼ 0.42). Toxicity of gastrazole was mild with significantly less diarrhoea (P ¼ 0.03), stomatitis (Po0.001) and hand -foot syndrome (Po0.001) compared to 5-FU. Quality of life (QoL) assessment showed similar QoL between gastrazole and 5-FU at baseline and no significant differences occurred with treatment either between arms or within arms. Compared to placebo, patients with advanced pancreatic cancer treated with gastrazole appeared to live longer, albeit in a very small trial and will require confirmation with large-scale randomised data. However, it did not produce survival advantage over PVI 5-FU. Lack of toxicity for gastrazole may allow its combination with cytotoxic drugs.

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Section: Discussionmentioning

confidence: 97%

Gastrazole (JB95008), a novel CCK2/gastrin receptor antagonist, in the treatment of advanced pancreatic cancer: results from two randomised controlled trials

et al. 2006

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“…Brett et al [44] first reported that the immunogen G17DT was capable of stimulating gastrin-specific antibodies in 20 of the 30 pancreatic cancer patients tested, and that survival in these immune responders was superior to that of non-responders (7.1 vs 4.0 months respectively, P=0.002). A subsequent randomized, double-blind, phase II study in pancreatic cancer patients unsuitable for or unwilling to take chemotherapy (n=154) found that G17DT provided a significant survival advantage (5.0 vs 2.5 months, P=0.03) and time to performance status decline (4.5 vs 2.6 months, P=0.04) as compared with placebo [45].…”

Section: Gastrin Immunogensmentioning

confidence: 96%

Chemotherapy for advanced pancreatic cancer: Past, present, and future

Friberg

Kindler

2005

Curr Oncol Rep

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Advanced pancreatic cancer is a devastating illness characterized by significant morbidity and a brief median survival. Although standard chemotherapy with gemcitabine achieves only modest improvements in survival and quality of life, classic cytotoxic agents, such as 5-fluorouracil, pemetrexed, irinotecan, exatecan, cisplatin, or oxaliplatin, given alone or in combination with gemcitabine, have not proved superior. Thus, more recent trials have focused on targeting the biologic characteristics of pancreatic cancer. Although phase III trials of farnesyl transferase and matrix metalloproteinase inhibitors have not improved survival, encouraging preliminary results have been observed in phase II studies of inhibitors of the vascular endothelial growth factor and the epidermal growth factor receptor.

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“…The first vaccine is called G17DT. 18,19 This vaccine was developed because it has been shown that pancreatic carcinomas express the cholecystokinin-2 receptor (CCK-2 receptor) which responds to gastrins as growth factors. The concept was to produce a vaccine which would be a gastrin immunogen so that after vaccination, circulating gastrin would be neutralized by the antibody.…”

Section: Therapeutic Vaccinesmentioning

confidence: 99%

What's new in pancreatic cancer treatment pipeline?

Hoff

2006

Best Practice & Research Clinical Gastroenterology

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Randomised, double blind, placebo-controlled, multi-centre, group-sequential trial of G17DT for patients with advanced pancreatic cancer unsuitable or unwilling to take chemotherapy

Cited by 21 publications

References 0 publications

Gastrazole (JB95008), a novel CCK2/gastrin receptor antagonist, in the treatment of advanced pancreatic cancer: results from two randomised controlled trials

Gastrazole (JB95008), a novel CCK2/gastrin receptor antagonist, in the treatment of advanced pancreatic cancer: results from two randomised controlled trials

Chemotherapy for advanced pancreatic cancer: Past, present, and future

What's new in pancreatic cancer treatment pipeline?

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