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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Head and Neck Cancer	Drug: Docetaxel; Drug: Cisplatin; Drug: Cetuximab; Drug: Carboplatin	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	27 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Weekly Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With SCCHN
Study Start Date :	October 2011
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	January 2021

Arms and Interventions

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Arm	Intervention/treatment
Experimental: cisplatin/docetaxel/cetuximab; Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.	Drug: Docetaxel; 30 mg/m2 iv; Other Name: Taxotere Drug: Cisplatin; 30 mg/m2 iv; Other Names: cisplatinum; Platinol; CDDP; cis-diamminedichloroplatinum(II); Platinol-AQ Drug: Cetuximab; C1: 400 mg/m2, thereafter 250 iv; Other Name: Erbitux Drug: Carboplatin; AUC 2 iv; Other Names: cis-Diammine(1,1-cyclobutanedicarboxylato)platinum(II); Paraplatin; Paraplatin-AQ

Outcome Measures

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Primary Outcome Measures :

1. Response rate [ Time Frame: 8 weeks ]

Secondary Outcome Measures :

1. Progression free survival [ Time Frame: 3 months ]
2. Overall survival [ Time Frame: 2 years ]

Eligibility Criteria

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Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

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Locations

United States, California
University of California Davis Medical Center
Davis, California, United States, 95616
Stanford University, School of Medicine
Stanford, California, United States, 95305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:	A. Dimitrios Colevas, MD	Stanford University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT01437449 History of Changes
Other Study ID Numbers:	ENT0033; SU-08222011-8290 ( Other Identifier: Stanford University ); 22329; NCI-2011-03271; 22329 ( Other Identifier: Stanford IRB )
First Posted:	September 20, 2011
Last Update Posted:	May 23, 2018
Last Verified:	May 2018

Keywords provided by Stanford University:

Quality of Life

Additional relevant MeSH terms:

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Docetaxel; Cisplatin; Carboplatin	Cetuximab; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action