Study in Locally Advanced Squamous Cell Carcinoma of Head and Neck

Phase 2 Terminated 50 enrolled University of Chicago Novartis Pharmaceuticals · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

Primary Compare response rates (relative change in tumor size) to induction chemotherapy consisting of cisplatin/paclitaxel/cetuximab +/- everolimus. Secondary: Determine the maximum administered dose (MAD), maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety of everolimus with cisplatin/paclitaxel/cetuximab induction chemotherapy (phase I portion)

Timeline

Start: 2010-05-04
Primary completion: 2015-01
Completion: 2015-01

Outcome

Missed primary endpoint

Stopped: “Primary endpoint reached futility boundary”

registry MEAN Everolimus: -0.609 (Standard Error 0.086) dimensionless (log ratio) MEAN Placebo: -0.796 (Standard Error 0.112) dimensionless (log ratio) NCT01133678 ↗

registry analysis (other test); Everolimus vs Placebo; p = 0.190; t-test, 2 sided; NCT01133678 ↗

paper The addition of everolimus to IC was not beneficial. PMID 26884588 ↗

Publications

Villaflor VM, Melotek JM, Karrison TG, Brisson RJ, Blair EA, Portugal L, De Souza JA, Ginat DT, Stenson KM, Langerman A, Kocherginsky M, Spiotto MT, Hannigan N, Seiwert TY, Cohen EE, Vokes EE, Haraf DJ. Response-adapted volume de-escalation (RAVD) in locally advanced head and neck cancer. Ann Oncol. 2016 May;27(5):908-13. doi: 10.1093/annonc/mdw051. Epub 2016 Feb 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	5 mg	Oral
Background	Cetuximab	Monoclonal antibody	250 mg/m2	—
Background	Cisplatin	Other / unclassified	75 mg/m2	—
Background	Hydroxyurea	Other / unclassified	500 mg	Oral
Background	Paclitaxel	Small molecule	100 mg/m2	Intravenous
Background	fluorouracil	Small molecule	600 mg/m2	Intravenous