Clinical trial · Interventional
Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Weekly Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With SCCHN
NCT01437449CI-TRIAL-00073388completedPhase 2Results postedClinicalTrials.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)
Docetaxel and cetuximab are FDA-approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Cisplatin and carboplatin, while not FDA-approved for SCCHN, have been used as standard of care in SCCHN patients in combination with other drugs. This study evaluates if weekly cisplatin and docetaxel, in combination with cetuximab, is effective in palliative treatment of patients with SCCHN. These drugs will be given intravenously weekly, repeated 3 of every 4 weeks until evidence of disease progression or unacceptable adverse events.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cisplatin + Docetaxel + Cetuximab
- description
- Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
- interventionNames
- Drug: Docetaxel
- Drug: Cisplatin
- Drug: Cetuximab
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 8 weeks
- description
- Clinical response for each participant will be assessed after 8 weeks of treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Overall response rate (ORR) was assessed as the sum of the number of participants that experience a complete response (CR) or partial response (PR). The outcome is defined and reported as the number of subjects that responded, a number without dispersion. Other response statuses are included. RECIST v1.1 criteria is defined as follows. * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
INCLUSION CRITERIA * Squamous cell carcinoma (SCC) of head and neck (SCCHN), including all pharynx, larynx, oral cavity, skin and para-nasal sinus sites. Patients with SCC of unknown primary presenting in the neck clinically compatible with head and neck mucosal primary sites are eligible. * If prior chemoradiation, radiation, and/or surgery in the potentially curative setting, \> 3 months has elapsed since the end of the potentially curative treatment ended * If history of other malignancies treated curatively \> 1 year prior to enrollment, no evidence of relapse at the time of enrollment * If brain metastasis, central nervous system (CNS) imaging documents no evidence of CNS progression at least 30 days following definitive CNS treatment (resection or radiation) * ≥ 16 years old * Eastern cooperative oncology group (ECOG) Performance Status \< 3 * Laboratory value requirements at enrollment: * Absolute neutrophil count \> 1500/mm³ * Platelet count \> 100,000/mm³ * Hemoglobin \> 8 g/dL * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \< 2.5 x upper limit of normal (ULN) unless liver metastases documented. If so, AST and ALT \< 5 x ULN required. * Total bilirubin \< 1.5 x ULN, EXCEPT if Gilbert's syndrome is present. If so, total bilirubin \< 2.5 x ULN * Serum Creatinine \< 1.5 mg/dL OR an estimated creatinine clearance from 24 hour urine collection \> 50 mL/min * Peripheral neuropathy \< grade 2 * Hearing loss in best ear \< grade 2 per Chang criteria if audiogram performed. Formal audiology is not required in patients with no clinical evidence of hearing loss at baseline. * Ability to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA * Prior palliative chemotherapy * Active infections including HIV (EXCEPTION: HIV-positive patients on HAART with undetectable blood HIV levels, or with history or serological evidence of exposure to Hepatitis B without active infection are eligible) * Prior grade 3 allergic or infusion reactions to docetaxel, cisplatin or cetuximab (EXCEPTION: a history of infusion reactions that were well-tolerated, at physician's discretion) * Pregnant and/or lactating
References
Publications (1)
- RESULTTrieu V, Pinto H, Riess JW, Lira R, Luciano R, Coty J, Boothroyd D, Colevas AD. Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck. Oncologist. 2018 Jul;23(7):764-e86. doi: 10.1634/theoncologist.2017-0618. Epub 2018 Mar 14. PMID 29540603