Sunitinib in Patients With Advanced Gastric Cancer and Treated With FOLFIRI

Summary

This trial will be conducted to evaluate the efficacy, safety and tolerability of SUNITINIB as add-on therapy with a widely used second-line palliative FOLFIRI chemotherapy in patients with chemo-refractory advanced or metastatic adenocarcinoma of stomach or lower esophagus (mGC). There is a clear scientific rationale for the use of Sunitinib to treat patients with mGC. Despite recent therapeutic advances, the median overall survival (OS) in patients with mG is still ≤ 12 months. Therefore, newer agents with novel mechanisms of action are desperately needed for treatment of these patients.

Timeline

Start

2009-11

Primary completion

2012-11

Completion

2013-07

Outcome

Missed primary endpoint

paper Median PFS was similar, 3.5 vs. 3.3 months (hazard ratio (HR) 1.11, 95 % CI 0.70-1.74, P = 0.66) PMID 27582078 ↗

paper Although sunitinib combined with FOLFIRI did not improve PFS and response in chemotherapy-resistant gastric cancer PMID 27582078 ↗

Publications

• Moehler M, Gepfner-Tuma I, Maderer A, Thuss-Patience PC, Ruessel J, Hegewisch-Becker S, Wilke H, Al-Batran SE, Rafiyan MR, Weissinger F, Schmoll HJ, Kullmann F, von Weikersthal LF, Siveke JT, Weusmann J, Kanzler S, Schimanski CC, Otte M, Schollenberger L, Koenig J, Galle PR. Sunitinib added to FOLFIRI versus FOLFIRI in patients with chemorefractory advanced adenocarcinoma of the stomach or lower esophagus: a randomized, placebo-controlled phase II AIO trial with serum biomarker program. BMC Cancer. 2016 Aug 31;16(1):699. doi: 10.1186/s12885-016-2736-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sunitinib	Small molecule	25 mg	Oral

Indications