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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01437449
First received: September 16, 2011
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: Docetaxel
Drug: Cisplatin
Drug: Cetuximab
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weekly Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With SCCHN

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Response rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: October 2011
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437449

Contacts
Contact: Ruth Lira 650-723-1367 rlira@stanford.edu
Contact: Cancer Clinical Trials Office 650-498-7061 ccto-office@stanford.edu

Locations
United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 95305
Contact: Stanford Cancer Clinical Trials Office    650-498-7061    ccto-office@stanford.edu   
Sub-Investigator: Heather A Wakelee, MD         
Sub-Investigator: Harlan Pinto, MD         
Sub-Investigator: Joel Neal, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: A. Dimitrious Colevas, MD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01437449     History of Changes
Other Study ID Numbers: ENT0033, SU-08222011-8290, 22329, NCI-2011-03271, 22329
Study First Received: September 16, 2011
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Quality of Life

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Cetuximab
Cisplatin
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014