Weekly Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Quality of Life
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Docetaxel Type: Drug
Name: Cisplatin Type: Drug
Name: Cetuximab Type: Drug
Name: Carboplatin Type: Drug
Overall Status
Recruiting
Summary
Docetaxel and cetuximab are FDA approved for the treatment of squamous cell carcinoma of the head and neck. Cisplatin and carboplatin, while not FDA approved for Squamous Cell Carcinoma of the Head and Neck (SCCHN), have been used as standard of care in patients with SCCHN in combination with other drugs. This study will determine if weekly cisplatin and docetaxel, in combination with cetuximab, will be effective in palliative treatment of patients with squamous cell carcinoma of the head and neck. These drugs will be given intravenously weekly, repeated 3 of every 4 weeks until evidence of disease progression or unacceptable adverse events.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 16 Years
Gender: Both
Criteria: Inclusion Criteria:

- Squamous cell carcinoma of head and neck sites, 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.

- Patients who have received prior chemoradiation, radiation, and/ or surgery in the potentially curative setting are eligible as long as 3 months has elapsed since the end of the potentially curative treatment ended.

- Patients must be greater than 16 years old.

- ECOG Performance Status < 3 at enrollment is required.

- Laboratory value requirements at enrollment:

- Absolute neutrophil count > 1500/mm3

- Platelet count >100K/mm3

- Hemoglobin > 8 g/dL

- AST and ALT < 2.5 x ULN unless liver metastases documented. In this latter case, AST and ALT < 5 x ULN required.

- Total Bilirubin < 1.5 x ULN unless the patient has Gilbert's syndrome, in which case T. Bilirubin < 2.5 x ULN required

- Serum Creatinine < 1.5 mg/dL OR an estimated creatinine clearance from 24 hour urine collection > 50 ml/min

- Clinical requirements at enrollment:

- Peripheral neuropathy < grade 2

- Hearing loss in best ear < grade 2 per Chang criteria if audiogram performed. *24 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:

- No prior palliative chemotherapy

- Patients with active infections including HIV are not eligible. HIV positive patients on HAART with undetectable blood HIV levels are eligible. Patients with a history or serological evidence of exposure to Hepatitis B without active infection are eligible for this study.

- Patients with prior grade 3 allergic or infusion reactions to docetaxel, cisplatin or cetuximab are not eligible. A history of well tolerated infusion reactions is NOT an exclusion.

- Pregnant women and/or nursing patients will be excluded from the study because of potential harm to the fetus or nursing infant.

- Because the primary endpoint of this study is response rate and not survival, patients with a history of other malignancies treated curatively greater than one year prior to enrollment and without evidence of relapse at the time of enrollment are eligible.

- Patients with brain metastasis are eligible only if by CNS imaging there is no evidence of CNS progression at least 30 days following definitive CNS treatment (resection or radiation).
Locations
University of California Davis Medical Center
Davis, California, United States
Status: Recruiting
Contact: Courtney Eddings - 916-734-3604
Stanford University Cancer Institute
Stanford, California, United States
Status: Recruiting
Contact: Risa Jiron - 650-736-1598 - rjiron@stanford.edu
Start Date
October 2011
Completion Date
January 2021
Sponsors
Stanford University
Source
Stanford University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page