drugset / Trial / NCT04770623
Docetaxel and Irinotecan in Gastric Cancer
NaSingle-groupOpen-labelTreatment
Summary
To assess the role of docetaxel and irinotecan combination in second line gastric cancer. The primary end point is response rate. Secondary end points are toxicity, PFS and OS.
Timeline
- Start
- 2021-03-05
- Primary completion
- 2023-01-09
- Completion
- 2023-01-09
Publications
- Background Catalano V, Graziano F, Santini D, D'Emidio S, Baldelli AM, Rossi D, Vincenzi B, Giordani P, Alessandroni P, Testa E, Tonini G, Catalano G. Second-line chemotherapy for patients with advanced gastric cancer: who may benefit? Br J Cancer. 2008 Nov 4;99(9):1402-7. doi: 10.1038/sj.bjc.6604732.
- Background Shitara K, Muro K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Yamaguchi K, Segawa Y, Omuro Y, Tamura T, Doi T, Yukisawa S, Yasui H, Nagashima F, Gotoh M, Esaki T, Emig M, Chandrawansa K, Liepa AM, Wilke H, Ichimiya Y, Ohtsu A. Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer. Gastric Cancer. 2016 Jul;19(3):927-38. doi: 10.1007/s10120-015-0559-z. Epub 2015 Oct 28.
- Background Tetzlaff ED, Cheng JD, Ajani JA. Review of docetaxel in the treatment of gastric cancer. Ther Clin Risk Manag. 2008 Oct;4(5):999-1007. doi: 10.2147/tcrm.s3226.
- Background Farhat FS. A general review of the role of irinotecan (CPT11) in the treatment of gastric cancer. Med Oncol. 2007;24(2):137-46. doi: 10.1007/BF02698032.
- Background Thuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, Dogan Y, Gebauer B, Schumacher G, Reichardt P. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011 Oct;47(15):2306-14. doi: 10.1016/j.ejca.2011.06.002.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 30 mg/m2 | Other |
| Subject | Irinotecan | Small molecule | 185 mg/m2 | Other |