publication . Article . 2018

SPIRE - combining SGI-110 with cisplatin and gemcitabine chemotherapy for solid malignancies including bladder cancer: study protocol for a phase Ib/randomised IIa open label clinical trial.

Crabb, S.; Danson, S.J.; Catto, J.W.F.; McDowell, C.; Lowder, J.N.; Caddy, J.; Dunkley, D.; Rajaram, J.; Ellis, D.; Hill, S.; ...
  • Published: 03 Apr 2018
Abstract
Background Urothelial bladder cancer (UBC) accounts for 10,000 new diagnoses and 5000 deaths annually in the UK (Cancer Research UK, http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bladder-cancer, Cancer Research UK, Accessed 26 Mar 2018). Cisplatin-based chemotherapy is standard of care therapy for UBC for both palliative first-line treatment of advanced/metastatic disease and radical neoadjuvant treatment of localised muscle invasive bladder cancer. However, cisplatin resistance remains a critical cause of treatment failure and a barrier to therapeutic advance in UBC. Based on supportive pre-clinical data, we hyp...
Subjects
free text keywords: Medicine (miscellaneous), Pharmacology (medical), Clinical trial, Intensive care medicine, medicine.medical_specialty, medicine, Bladder cancer, medicine.disease, Cystectomy, medicine.medical_treatment, Clinical endpoint, Cisplatin, medicine.drug, Neoadjuvant therapy, Internal medicine, Chemotherapy, Gemcitabine, Oncology, business.industry, business, Urothelial bladder cancer, Guadecitabine, DNA methyltransferase inhibitor, Phase I/II, Randomised controlled trial, Cisplatin resistance, Medicine (General), R5-920, Study Protocol
Communities
Digital Humanities and Cultural Heritage
31 references, page 1 of 3

1. Cancer Research UK. http://www.cancerresearchuk.org/health-professional/ cancer-statistics/statistics-by-cancer-type/bladder-cancer. Accessed 26 Mar 2018.

2. Grossman HB, Natale RB, Tangen CM, White RW, Sarosdy MF, Wood DP, et al. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced. Bladder Cancer. 2003;349:859-66.

3. International Collaboration of Trialists, Medical Research Council Advanced Bladder Cancer Working Party (now the National Cancer Research Institute Bladder Cancer Clinical Studies Group), European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group, Australian Bladder Cancer Study Group, National Cancer Institute of Canada Clinical Trials Group, Finnbladder; Norwegian Bladder Cancer Study Group, Club Urologico Espanol de Tratamiento Oncologico Group, Griffiths G, Hall R, Sylvester R, Raghavan D, Parmar MK. International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: Long-term results of the BA06 30894 trial. J Clin Oncol. 2011;29:2171-7.

4. Von Der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: Results of a Large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000; 18:3068-77. [OpenAIRE]

5. Crabb SJ, Wheater M. Advances in chemotherapy and targeted systemic therapies for urothelial cancer. Curr Drug Ther. 2010;5:17-28.

6. Vale CL. Neoadjuvant chemotherapy in invasive bladder cancer: update of a systematic review and meta-analysis of individual patient data advanced bladder cancer (ABC) meta-analysis collaboration. Eur Urol. 2005;48:202-6.

7. Von Der Maase H, Sengelov L, Roberts JT, Ricci S, Dogliotti L, Oliver T, et al. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005;23:4602-8.

8. Bellmunt J, de Wit R, Vaughn DJ, Fradet Y, Lee JL, Fong L, et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med. 2016;376:1015-26.

9. Drayton RN, Dudziec E, Peter S, Hartmann A, Bryant HE, Catto JW. Reduced expression of miRNA-27a modulates cisplatin resistance in bladder cancer by targeting the cystine/glutamate exchanger SLC7A11. Clin Cancer Res. 2014;20:1990-2000. [OpenAIRE]

10. Dudziec E, Gogl-Doring A, Cookson V, Chen W, Catto JWR. Integrated epigenome profiling of repressive histone modifications DNA methylation and gene expression in normal and malignant urothelial cells. PLoS One. 2012;7:e32750. [OpenAIRE]

11. Cheng JC, Matsen CB, Gonzales FA, Ye W, Greer S, Marquez VE, et al. Inhibition of DNA methylation and reactivation of silenced genes by zebularine. J Natl Cancer Inst. 2003;95:399-409. [OpenAIRE]

12. Christoph F, Kempkensteffen C, Weikert S, Köllermann J, Krause H, Miller K, et al. Methylation of tumour suppressor genes APAF-1 and DAPK-1 and in vitro effects of demethylating agents in bladder and kidney cancer. Br J Cancer. 2006;95:1701-7.

13. Shang D, Liu Y, Matsui Y, Ito N, Nishiyama H, Kamoto T, et al. Demethylating agent 5-aza-2′-deoxycytidine enhances susceptibility of bladder transitional cell carcinoma to cisplatin. Urology. 2008;71:1220-5.

14. Ramachandran K, Gordian E, Singal R. 5-Azacytidine reverses drug resistance in bladder cancer cells. Anticancer Res. 2011;31:3757-66.

15. Huihui Zhang, Fan Qi, Youhan Cao, Xiongbing Zu, Minfeng Chen, Zhuo Li and LQ. 5-Aza-2'Deoxycytidine Enhances Maspin Expression and Inhibits Proliferation, Migration, and Invasion of the Bladder Cancer T24 Cell Line. Cancer Biother Radiopharm. 2013;28:343-50.

31 references, page 1 of 3
Abstract
Background Urothelial bladder cancer (UBC) accounts for 10,000 new diagnoses and 5000 deaths annually in the UK (Cancer Research UK, http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bladder-cancer, Cancer Research UK, Accessed 26 Mar 2018). Cisplatin-based chemotherapy is standard of care therapy for UBC for both palliative first-line treatment of advanced/metastatic disease and radical neoadjuvant treatment of localised muscle invasive bladder cancer. However, cisplatin resistance remains a critical cause of treatment failure and a barrier to therapeutic advance in UBC. Based on supportive pre-clinical data, we hyp...
Subjects
free text keywords: Medicine (miscellaneous), Pharmacology (medical), Clinical trial, Intensive care medicine, medicine.medical_specialty, medicine, Bladder cancer, medicine.disease, Cystectomy, medicine.medical_treatment, Clinical endpoint, Cisplatin, medicine.drug, Neoadjuvant therapy, Internal medicine, Chemotherapy, Gemcitabine, Oncology, business.industry, business, Urothelial bladder cancer, Guadecitabine, DNA methyltransferase inhibitor, Phase I/II, Randomised controlled trial, Cisplatin resistance, Medicine (General), R5-920, Study Protocol
Communities
Digital Humanities and Cultural Heritage
31 references, page 1 of 3

1. Cancer Research UK. http://www.cancerresearchuk.org/health-professional/ cancer-statistics/statistics-by-cancer-type/bladder-cancer. Accessed 26 Mar 2018.

2. Grossman HB, Natale RB, Tangen CM, White RW, Sarosdy MF, Wood DP, et al. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced. Bladder Cancer. 2003;349:859-66.

3. International Collaboration of Trialists, Medical Research Council Advanced Bladder Cancer Working Party (now the National Cancer Research Institute Bladder Cancer Clinical Studies Group), European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group, Australian Bladder Cancer Study Group, National Cancer Institute of Canada Clinical Trials Group, Finnbladder; Norwegian Bladder Cancer Study Group, Club Urologico Espanol de Tratamiento Oncologico Group, Griffiths G, Hall R, Sylvester R, Raghavan D, Parmar MK. International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: Long-term results of the BA06 30894 trial. J Clin Oncol. 2011;29:2171-7.

4. Von Der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: Results of a Large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000; 18:3068-77. [OpenAIRE]

5. Crabb SJ, Wheater M. Advances in chemotherapy and targeted systemic therapies for urothelial cancer. Curr Drug Ther. 2010;5:17-28.

6. Vale CL. Neoadjuvant chemotherapy in invasive bladder cancer: update of a systematic review and meta-analysis of individual patient data advanced bladder cancer (ABC) meta-analysis collaboration. Eur Urol. 2005;48:202-6.

7. Von Der Maase H, Sengelov L, Roberts JT, Ricci S, Dogliotti L, Oliver T, et al. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005;23:4602-8.

8. Bellmunt J, de Wit R, Vaughn DJ, Fradet Y, Lee JL, Fong L, et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med. 2016;376:1015-26.

9. Drayton RN, Dudziec E, Peter S, Hartmann A, Bryant HE, Catto JW. Reduced expression of miRNA-27a modulates cisplatin resistance in bladder cancer by targeting the cystine/glutamate exchanger SLC7A11. Clin Cancer Res. 2014;20:1990-2000. [OpenAIRE]

10. Dudziec E, Gogl-Doring A, Cookson V, Chen W, Catto JWR. Integrated epigenome profiling of repressive histone modifications DNA methylation and gene expression in normal and malignant urothelial cells. PLoS One. 2012;7:e32750. [OpenAIRE]

11. Cheng JC, Matsen CB, Gonzales FA, Ye W, Greer S, Marquez VE, et al. Inhibition of DNA methylation and reactivation of silenced genes by zebularine. J Natl Cancer Inst. 2003;95:399-409. [OpenAIRE]

12. Christoph F, Kempkensteffen C, Weikert S, Köllermann J, Krause H, Miller K, et al. Methylation of tumour suppressor genes APAF-1 and DAPK-1 and in vitro effects of demethylating agents in bladder and kidney cancer. Br J Cancer. 2006;95:1701-7.

13. Shang D, Liu Y, Matsui Y, Ito N, Nishiyama H, Kamoto T, et al. Demethylating agent 5-aza-2′-deoxycytidine enhances susceptibility of bladder transitional cell carcinoma to cisplatin. Urology. 2008;71:1220-5.

14. Ramachandran K, Gordian E, Singal R. 5-Azacytidine reverses drug resistance in bladder cancer cells. Anticancer Res. 2011;31:3757-66.

15. Huihui Zhang, Fan Qi, Youhan Cao, Xiongbing Zu, Minfeng Chen, Zhuo Li and LQ. 5-Aza-2'Deoxycytidine Enhances Maspin Expression and Inhibits Proliferation, Migration, and Invasion of the Bladder Cancer T24 Cell Line. Cancer Biother Radiopharm. 2013;28:343-50.

31 references, page 1 of 3
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