Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer

Summary

This randomized phase III trial studies gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride and cisplatin in treating patients with urinary tract cancer that has spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with bevacizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given with or without bevacizumab in treating patients with urinary tract cancer.

Timeline

Start

2009-07-15

Primary completion

2018-11-02

Completion

2021-06-15

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm II (GCB) vs Arm I (GCP); p = 0.1707; Hazard Ratio (HR) 0.87 (95% CI 0.72 to 1.06); Log Rank NCT00942331 ↗

paper The addition of bevacizumab to GC did not result in improved OS. PMID 33989025 ↗

Publications

• Iyer G, Choi W, Luo B, Carvalho F, Hanlon T, Reis H, Guercio BJ, Fong M, Mountain J, Feng M, Regazzi AM, McCart L, Wen Y, Al-Ahmadie H, Mouw KW, Van Allen EM, Bellmunt J, Dreicer R, Flaig TW, Halabi S, McConkey DJ, Rosenberg JE. Relationship Among DNA Damage Response Gene Alterations, Molecular Subtypes, and Survival Outcomes in Patients With Metastatic Bladder Cancer Treated on CALGB 90601. JCO Precis Oncol. 2025 Jul;9:e2400938. doi: 10.1200/PO-24-00938. Epub 2025 Jul 1.
• Guercio BJ, Whiting K, Shah RH, Ballman KV, Halabi S, Regazzi AM, Milbank JH, Bajorin DF, Beltran H, Morris MJ, Solit DB, Berger MF, Iyer G, Seshan V, Rosenberg JE. Circulating Tumor DNA and Response to Cisplatin-based Chemotherapy in Patients with Metastatic Urothelial Carcinoma Enrolled in CALGB 90601 (Alliance). Eur Urol Open Sci. 2025 Apr 7;75:80-88. doi: 10.1016/j.euros.2025.03.009. eCollection 2025 May.
• Rosenberg JE, Ballman KA, Halabi S, Atherton PJ, Mortazavi A, Sweeney C, Stadler WM, Teply BA, Picus J, Tagawa ST, Katragadda S, Vaena D, Misleh J, Hoimes C, Plimack ER, Flaig TW, Dreicer R, Bajorin D, Hahn O, Small EJ, Morris MJ. Randomized Phase III Trial of Gemcitabine and Cisplatin With Bevacizumab or Placebo in Patients With Advanced Urothelial Carcinoma: Results of CALGB 90601 (Alliance). J Clin Oncol. 2021 Aug 1;39(22):2486-2496. doi: 10.1200/JCO.21.00286. Epub 2021 May 14.

Drugs

Indications