drugset / Trial / NCT01261728
Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma
Phase 2
Completed
57 enrolled
Memorial Sloan Kettering Cancer Center
Hartford Hospital · collabMayo Clinic · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin for four 21 day cycles for a total of 12 weeks can help shrink the tumor before undergoing surgery for kidney cancer.
Timeline
- Start
- 2010-12-14
- Primary completion
- 2025-08-06
- Completion
- 2025-08-06
Publications
- Coleman JA, Yip W, Wong NC, Sjoberg DD, Bochner BH, Dalbagni G, Donat SM, Herr HW, Cha EK, Donahue TF, Pietzak EJ, Hakimi AA, Kim K, Al-Ahmadie HA, Vargas HA, Alvim RG, Ghafoor S, Benfante NE, Meraney AM, Shichman SJ, Kamradt JM, Nair SG, Baccala AA Jr, Palyca P, Lash BW, Rizvi MA, Swanson SK, Muina AF, Apolo AB, Iyer G, Rosenberg JE, Teo MY, Bajorin DF. Multicenter Phase II Clinical Trial of Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy for Patients With High-Grade Upper Tract Urothelial Carcinoma. J Clin Oncol. 2023 Mar 10;41(8):1618-1625. doi: 10.1200/JCO.22.00763. Epub 2023 Jan 5.
- Hird AE, Magee DE, Cheung DC, Sander B, Sridhar S, Nam RK, Kulkarni GS. Neoadjuvant Versus Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: A Microsimulation Model. Clin Genitourin Cancer. 2021 Apr;19(2):e135-e147. doi: 10.1016/j.clgc.2020.10.001. Epub 2020 Oct 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 35 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |