Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

Phase 2 Terminated 14 enrolled Emory University Sanofi · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum (cisplatin) and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.

Timeline

Start: 2006-08
Primary completion: 2009-09
Completion: 2009-09

Outcome

Outcome not reported

Stopped: “Safety reasons”

Publications

Results Saba NF, Magliocca KR, Kim S, Muller S, Chen Z, Owonikoko TK, Sarlis NJ, Eggers C, Phelan V, Grist WJ, Chen AY, Ramalingam SS, Chen ZG, Beitler JJ, Shin DM, Khuri FR, Marcus AI. Acetylated tubulin (AT) as a prognostic marker in squamous cell carcinoma of the head and neck. Head Neck Pathol. 2014 Mar;8(1):66-72. doi: 10.1007/s12105-013-0476-6. Epub 2013 Jul 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	100 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	1000 mg/m2	—