drugset / Trial / NCT00139269
Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Phase 1/2
Completed
38 enrolled
Dana-Farber Cancer Institute
Brigham and Women's Hospital · collabSanofi · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the appropriate dose, that dose which is found to give maximum effect with limited toxicity, of cisplatin in combination with docetaxel and 5-fluorouracil and then to further define the safety and effectiveness of this combination of medications.
Timeline
- Start
- 1998-02
- Primary completion
- 2006-12
- Completion
- 2006-12
Publications
- Background Posner MR, Glisson B, Frenette G, Al-Sarraf M, Colevas AD, Norris CM, Seroskie JD, Shin DM, Olivares R, Garay CA. Multicenter phase I-II trial of docetaxel, cisplatin, and fluorouracil induction chemotherapy for patients with locally advanced squamous cell cancer of the head and neck. J Clin Oncol. 2001 Feb 15;19(4):1096-104. doi: 10.1200/JCO.2001.19.4.1096.
- 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 | — | Intravenous |
| Subject | Docetaxel | Small molecule | — | Intravenous |
| Subject | fluorouracil | Small molecule | — | Intravenous |