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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01437449
Recruitment Status : Active, not recruiting
First Posted : September 20, 2011
Last Update Posted : May 23, 2018
Information provided by (Responsible Party):
Stanford University

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care
U.S. FDA Resources

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

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 ]

Information from the National Library of Medicine

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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01437449

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
Principal Investigator: A. Dimitrios Colevas, MD Stanford University

Responsible Party: Stanford University Identifier: NCT01437449     History of Changes
Other Study ID Numbers: ENT0033
SU-08222011-8290 ( Other Identifier: Stanford University )
22329 ( Other Identifier: Stanford IRB )
First Posted: September 20, 2011    Key Record Dates
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
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action