drugset / Trial / NCT01762150
Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical research study is to learn the effectiveness of sorafenib combined with gemcitabine plus cisplatin in the treatment of patients with locally advanced or metastatic collecting duct carcinoma(CDC) of the kidney. The safety of each treatment will also be studied.
Timeline
- Start
- 2011-06
- Primary completion
- 2016-12
- Completion
- 2018-06
Publications
- Background Oudard S, Banu E, Vieillefond A, Fournier L, Priou F, Medioni J, Banu A, Duclos B, Rolland F, Escudier B, Arakelyan N, Culine S; GETUG (Groupe d'Etudes des Tumeurs Uro-Genitales). Prospective multicenter phase II study of gemcitabine plus platinum salt for metastatic collecting duct carcinoma: results of a GETUG (Groupe d'Etudes des Tumeurs Uro-Genitales) study. J Urol. 2007 May;177(5):1698-702. doi: 10.1016/j.juro.2007.01.063.
- Background Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. doi: 10.1056/NEJMoa060655.
- Sheng X, Cao D, Yuan J, Zhou F, Wei Q, Xie X, Cui C, Chi Z, Si L, Li S, Mao L, Lian B, Tang B, Yan X, Wang X, Kong Y, Dai J, Bai X, Zhou L, Guo J. Sorafenib in combination with gemcitabine plus cisplatin chemotherapy in metastatic renal collecting duct carcinoma: A prospective, multicentre, single-arm, phase 2 study. Eur J Cancer. 2018 Sep;100:1-7. doi: 10.1016/j.ejca.2018.04.007. Epub 2018 Jun 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Sorafenib | Small molecule | 400 mg | Oral |