Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Phase 2

Completed

Interventions: Drug: Docetaxel
Drug: Cisplatin
Drug: Cetuximab
Drug: Carboplatin

Brief Summary: 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.

Detailed Description: Primary Objective:To establish the response rate using RECIST 1 criteria to weekly TPC in patients with metastatic or relapsed squamous cell carcinoma of the head and neck Secondary Objective: To establish the safety profile, progression free and overall survival of weekly TPC in this patient population.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Cisplatin + Docetaxel + Cetuximab	Carboplatin	Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
Cisplatin + Docetaxel + Cetuximab	Docetaxel	Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
Cisplatin + Docetaxel + Cetuximab	Cisplatin	Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
Cisplatin + Docetaxel + Cetuximab	Cetuximab	Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	8 weeks	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

Secondary Outcome Measures

Name	Time	Method
Grade 3, 4, and 5 Related Adverse Events (Toxicities)	2 years	Related adverse events are considered toxicities. The outcome was assessed as adverse events and serious adverse events (SAEs per 21CFR§312.32) at least Grade 3, and are reported as the number of toxicities by grade (3, 4 or 5), a number without dispersion.
Progression-free Survival (PFS)	24 months	Progression-free survival (PFS), defined as the duration of time from start of treatment to time of progression or death, was assessed through 24 months, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. The outcome is reported as the median time that participants remained free of progression, with 95% confidence interval (CI). * 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
Overall Survival (OS)	24 months	Overall survival (OS) was assessed through 24 months. The outcome is reported as the median time that participants remained alive, with 95% CI.

Locations (2): Stanford University, School of Medicine
🇺🇸
Stanford, California, United States
University of California Davis Medical Center
🇺🇸
Davis, California, United States