Clinical trial · Interventional
Combination Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
TPLF-4, Compressed TPLF for Locally Advanced Squamous Cell Carcinoma
NCT00139230CI-TRIAL-00001498completedPhase 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 further test a combination chemotherapy regimen for the treatment of squamous cell carcinoma of the head and neck and to see if the addition of supportive medicine can help reduce the side effects of these drugs.
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/Neck | Head and Neck Squamous Cell Carcinoma | PROBABILISTIC | 0.70 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Ciprofloxacin | Drug | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Taxotere | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the safety of a four day regimen of taxotere, cisplatin, 5-fluorouracil and high-dose leucovorin with growth factor support and ciprofloxacin.
Secondary outcomes (1)
- measure
- To determine the efficacy of this regimen in patients with advances, previously untreated squamous cell carcinoma of the head and neck.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic confirmation of squamous cell carcinoma of head and neck. * All patients with previously untreated Stage III or IV. * Measurable disease * Complete recovery from previous diagnostic or therapeutic procedures. * Life expectancy greater than 3 months * Creatinine less than or equal to 1.5 * SGOT less than 1.5 x ULN * Alkaline phosphatase less than 2.5 x ULN * WBC greater than or equal to 4,000/mm * Platelet count greater than to equal to 100,000/mm * Hemoglobin greater than or equal to 10gm/dl * Patients of childbearing age must use effective contraception methods. Exclusion Criteria: * Patients with previous head and neck cancer except those treated with surgery only. * Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. * Peripheral neuropathy exceeding grade 1. * Cardiovascular or pulmonary disease * Pregnant or breastfeeding women
References
Publications (4)
- 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
- 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
- BACKGROUNDGoguen LA, Posner MR, Tishler RB, Wirth LJ, Norris CM, Annino DJ, Sullivan CA, Li Y, Haddad RI. Examining the need for neck dissection in the era of chemoradiation therapy for advanced head and neck cancer. Arch Otolaryngol Head Neck Surg. 2006 May;132(5):526-31. doi: 10.1001/archotol.132.5.526. PMID 16702569
- BACKGROUNDHaddad R, Tishler R, Wirth L, Norris CM, Goguen L, Sullivan C, O'Donnell L, Li Y, Posner M. Rate of pathologic complete responses to docetaxel, cisplatin, and fluorouracil induction chemotherapy in patients with squamous cell carcinoma of the head and neck. Arch Otolaryngol Head Neck Surg. 2006 Jun;132(6):678-81. doi: 10.1001/archotol.132.6.678. PMID 16785415