Evaluation of TRANSKRIP ® Plus Chemotherapy in Recurrent-Persistent Cervical Cancer

Summary

The purpose of this study is to determine the efficacy and safety the combination of TRANSKRIP ® vs placebo plus Carboplatin/Paclitaxel as first line treatment in patients with recurrent-persistent cervical cancer.

Timeline

Start

2015-01-01

Primary completion

2018-07

Completion

2018-08

Outcome

Outcome not reported

Stopped: “Due to a lack of sufficient resources, the opening was not carried out.”

Publications

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• Background Lee JS, Kim HS, Park JT, Lee MC, Park CS. Expression of vascular endothelial growth factor in the progression of cervical neoplasia and its relation to angiogenesis and p53 status. Anal Quant Cytol Histol. 2003 Dec;25(6):303-11.
• Background Lee SL, Tameru AM. A Mathematical Model of Human Papillomavirus (HPV) in the United States and its Impact on Cervical Cancer. J Cancer. 2012;3:262-8. doi: 10.7150/jca.4161. Epub 2012 Jun 9.
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• Background Louie KS, Castellsague X, de Sanjose S, Herrero R, Meijer CJ, Shah K, Munoz N, Bosch FX; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Smoking and passive smoking in cervical cancer risk: pooled analysis of couples from the IARC multicentric case-control studies. Cancer Epidemiol Biomarkers Prev. 2011 Jul;20(7):1379-90. doi: 10.1158/1055-9965.EPI-11-0284. Epub 2011 May 24.
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• Background Monk BJ, Sill MW, Burger RA, Gray HJ, Buekers TE, Roman LD. Phase II trial of bevacizumab in the treatment of persistent or recurrent squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2009 Mar 1;27(7):1069-74. doi: 10.1200/JCO.2008.18.9043. Epub 2009 Jan 12.
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• Background Moore DH, Blessing JA, McQuellon RP, Thaler HT, Cella D, Benda J, Miller DS, Olt G, King S, Boggess JF, Rocereto TF. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2004 Aug 1;22(15):3113-9. doi: 10.1200/JCO.2004.04.170.
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• Background Lewis MJ. Análisis de la situación del cáncer cervicouterino en América Latina y el Caribe. Washington, D.C. Organización Panamericana de la Salud / Organización Mundial de la Salud (OPS/OMS); 2004:40.
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• Background Tinker AV, Bhagat K, Swenerton KD, Hoskins PJ. Carboplatin and paclitaxel for advanced and recurrent cervical carcinoma: the British Columbia Cancer Agency experience. Gynecol Oncol. 2005 Jul;98(1):54-8. doi: 10.1016/j.ygyno.2005.03.037.
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• Background Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJ, Peto J, Meijer CJ, Munoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999 Sep;189(1):12-9. doi: 10.1002/(SICI)1096-9896(199909)189:13.0.CO;2-F.
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• Background Zambrano P, Segura-Pacheco B, Perez-Cardenas E, Cetina L, Revilla-Vazquez A, Taja-Chayeb L, Chavez-Blanco A, Angeles E, Cabrera G, Sandoval K, Trejo-Becerril C, Chanona-Vilchis J, Duenas-Gonzalez A. A phase I study of hydralazine to demethylate and reactivate the expression of tumor suppressor genes. BMC Cancer. 2005 Apr 29;5:44. doi: 10.1186/1471-2407-5-44.

Drugs

Indications