drugset / Trial / NCT00139243
Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
Phase 1/2
Completed
30 enrolled
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center · collabBrigham and Women's Hospital · collabMassachusetts General Hospital · collabSanofi · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily assess whether the combination is effective in treating squamous cell carcinoma of the head and neck.
Timeline
- Start
- 1997-10
- Primary completion
- 2006-01
- Completion
- 2006-01
Publications
- Background Colevas AD, Norris CM, Tishler RB, Lamb CC, Fried MP, Goguen LA, Gopal HV, Costello R, Read R, Adak S, Posner MR. Phase I/II trial of outpatient docetaxel, cisplatin, 5-fluorouracil, leucovorin (opTPFL) as induction for squamous cell carcinoma of the head and neck (SCCHN). Am J Clin Oncol. 2002 Apr;25(2):153-9. doi: 10.1097/00000421-200204000-00010.
- Background Haddad R, Colevas AD, Tishler R, Busse P, Goguen L, Sullivan C, Norris CM, Lake-Willcutt B, Case MA, Costello R, Posner M. Docetaxel, cisplatin, and 5-fluorouracil-based induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck: the Dana Farber Cancer Institute experience. Cancer. 2003 Jan 15;97(2):412-8. doi: 10.1002/cncr.11063.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | — | — |
| Subject | Docetaxel | Small molecule | — | Intravenous |
| Subject | Leucovorin | Small molecule | — | — |
| Subject | fluorouracil | Small molecule | — | — |