Phase 2 N=27 Treatment

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

Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01437449 ↗

Enrolled (actual)

Serious AEs

100.0%

Results posted

Dec 2019

Primary outcome: Primary: Overall Response Rate (ORR) — 1; 14; 15; 5 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Docetaxel (Drug); Cisplatin (Drug); Cetuximab (Drug); Carboplatin (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Response Rate (ORR)	1; 14; 15; 5; 6	—
SECONDARY Progression-free Survival (PFS)	4.8	—
SECONDARY Overall Survival (OS)	14.7	—
SECONDARY Grade 3, 4, and 5 Related Adverse Events (Toxicities)	24	—

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.

Eligibility Criteria

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 1500/mm³
Platelet count > 100,000/mm³
Hemoglobin > 8 g/dL
Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01437449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.