Clinical trial · Interventional
Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer
A Phase II Trial of Docetaxel, Cetuximab (C225), and Cisplatin Followed by Radiation, Cetuximab, and Cisplatin in Locally Advanced Head and Neck Cancer
NCT00226239CI-TRIAL-00028537completedPhase 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)
The purpose of this study is to determine if the addition of a unique targeted agent called Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of standard treatment with chemotherapy and radiation.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Head and neck cancer patients
- description
- Induction chemotherapy consists of 3 cycles of cisplatin 75 mg/m\^2, on day 1, docetaxel 75 mg/m\^2, on day 1, and cetuximab weekly days 1,8,15, repeated every 21 days (cetuximab dose is 400 mg/m\^2 on day 1 and 250 mg/m\^2 on subsequent weekly treatments). After 3 cycles of induction, patients receive standard radiation 70 Gy/200 cGy/daily, 5 days/week with concurrent weekly cisplatin 30 mg/m\^2 and cetuximab 250 mg/m\^2. After completing radiation therapy, patients receive cetuximab weekly as maintenance therapy for 6 months (see section 5 for detailed treatment plan and dose modifications)
- interventionNames
- Drug: Docetaxel
- Drug: Cisplatin
- Drug: Cetuximab
- Procedure: Radiation Therapy
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to 36 months
- description
- Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Stage III-IVB head and neck cancer, all sites, including unknown primary tumors (bulky stage II (T2N0) lesions of the base of tongue or hypopharynx and patients with stage II nasopharyngeal cancer are also eligible) Prior to study entry the resectability and alternative treatment options will be determined by a team composed of an Ear, Nose, and Throat Surgeon, a Radiation Oncologist and a Medical Oncologist. Stage determination, optimal local treatment, and its timing according to this protocol will be determined at this evaluation. Unequivocal demonstration of distant metastasis (M1) confers ineligibility 2. Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas, or WHO types I-III of the nasopharynx 3. Unidimensionally-measurable disease is required (RECIST) 4. No prior chemotherapy, biologic/molecular targeted therapy (including any prior therapy which specifically and directly targets the EGFR pathway), or radiotherapy for head and neck cancer 5. Prior surgical therapy will consist only of incisional or excisional biopsy and organ sparing procedures such as debulking of airway compromising tumors or neck dissection in a patient with an existing primary tumor (Any non-biopsy procedure must have taken place \> 4 weeks but \< 3 months of initiating protocol treatment) 6. ECOG PS 0 or 1; 7. Organ \& marrow function per protocol criteria and 8. Age of \>=18 years Exclusion Criteria: 1. History of severe allergic reactions attributed to docetaxel or compounds of similar chemical or biologic composition to docetaxel, or other drugs formulated with polysorbate 80 2. Uncontrolled intercurrent illness or significant history of uncontrolled cardiac disease 3. Receiving any other investigational agents 4. No history of prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, or malignancy that has been treated with a curative intent with a 5-year disease-free survival 5. Significant baseline sensory or motor neurologic deficits (\> grade I neuropathy); 6. HIV-positive patients and 7. Prior severe infusion reaction to a monoclonal antibody.
References
Publications (1)
- DERIVEDPsyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23. PMID 25057165