Selumetinib and Akt Inhibitor MK2206 or mFOLFOX Therapy Comprising Oxaliplatin and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer Previously Treated With Chemotherapy

Summary

This randomized phase II trial studies how well selumetinib and Akt inhibitor MK2206 work compared to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) therapy in treating patients with metastatic pancreatic cancer previously treated with chemotherapy. Selumetinib and Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet know whether selumetinib and Akt inhibitor MK2206 are more effective than oxaliplatin and fluorouracil in treating patients with metastatic pancreatic cancer.

Timeline

Start

2012-08

Primary completion

2015-06

Completion

2015-06

Outcome

Missed primary endpoint

registry mFOLFOX vs MK2206 and Selumetinib; p = 0.15; Log Rank NCT01658943 ↗

paper Dual targeting of the MEK and PI3K/AKT pathways downstream of KRAS by selumetinib plus MK-2206 did not improve overall survival PMID 27978579 ↗

Publications

• Chung V, McDonough S, Philip PA, Cardin D, Wang-Gillam A, Hui L, Tejani MA, Seery TE, Dy IA, Al Baghdadi T, Hendifar AE, Doyle LA, Lowy AM, Guthrie KA, Blanke CD, Hochster HS. Effect of Selumetinib and MK-2206 vs Oxaliplatin and Fluorouracil in Patients With Metastatic Pancreatic Cancer After Prior Therapy: SWOG S1115 Study Randomized Clinical Trial. JAMA Oncol. 2017 Apr 1;3(4):516-522. doi: 10.1001/jamaoncol.2016.5383.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MK-2206	Small molecule	135 mg	Oral
Subject	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Subject	Selumetinib	Small molecule	100 mg	Oral
Subject	fluorouracil	Small molecule	2400 mg/m2	Intravenous

Indications