Study of Gemcitabine+Platinum Salt+Bevacizumab Combination for Metastatic Collecting Duct Carcinoma (GETUG-AFU 24)

Summary

Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinum salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma.

Timeline

Start

2014-12

Primary completion

2020-03

Completion

2020-08

Outcome

Missed primary endpoint

paper At interim analysis, the trial was closed due to toxicity and lack of efficacy. PMID 37054556 ↗

paper Our study showed no benefit for bevacizumab added to chemotherapy in metastatic RMC and CDC with higher than expected toxicity. PMID 37054556 ↗

Publications

• Thibault C, Flechon A, Albiges L, Joly C, Barthelemy P, Gross-Goupil M, Chevreau C, Coquan E, Rolland F, Laguerre B, Gravis G, Pecuchet N, Elaidi RT, Timsit MO, Brihoum M, Auclin E, de Reynies A, Allory Y, Oudard S. Gemcitabine plus platinum-based chemotherapy in combination with bevacizumab for kidney metastatic collecting duct and medullary carcinomas: Results of a prospective phase II trial (BEVABEL-GETUG/AFU24). Eur J Cancer. 2023 Jun;186:83-90. doi: 10.1016/j.ejca.2023.03.018. Epub 2023 Mar 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	15 mg/kg	—

Indications