Clinical trial · Interventional
Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
A Phase I/II Study of Taxotere, Cisplatin, 5-Fluorouracil and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
NCT00139243CI-TRIAL-00001503completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma of Head and/or Neck | — | UNRESOLVED | — |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Taxotere | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the maximum tolerated dose of taxotere, cisplatin, 5-fluorouracil and leucovorin.
Secondary outcomes (2)
- measure
- To evaluate the side effects of a four day outpatient regimen with taxotere, cisplatin, 5-fluorouracil and leucovorin
- measure
- to obtain preliminary information about the effectiveness of the drug combination.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic documentation of squamous cell carcinoma of head and neck * Patients will previously untreated stage III or IV squamous cell carcinoma. * Patients with locally recurrent disease after surgery. * Life expectancy of longer than 3 months. * Kidney function: 1.5 or a 24 hour creatinine clearance of \> 30ml/min * Liver function: SGOT \< 1.5 X upper normal limit and alkaline phosphatase of \< 2.5 X upper normal limit. * WBC greater than or equal to 4,000/mm * Platelet count greater than or equal to 100,000/mm * Hemoglobin greater than or equal to 10gm/dl * Patients of child-bearing age must use effective methods of contraception. Exclusion Criteria: * Patients treated with previous chemotherapy or radiotherapy for head and neck cancer. * Patients with concurrent malignancy of any site except limited basal cell carcinoma, squamous carcinoma of the skin or carcinoma in situ of the cervix. * Pregnant or breast-feeding women
References
Publications (2)
- BACKGROUNDColevas 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. PMID 11943893
- BACKGROUNDHaddad 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. PMID 12518365