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Status:

COMPLETED

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

Lead Sponsor:

Stanford University

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

16+ years

Phase:

PHASE2

Brief 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 stand...

Detailed Description

Primary Objective:To establish the response rate using RECIST 1 criteria to weekly TPC in patients with metastatic or relapsed squamous cell carcinoma of the head and neck Secondary Objective: To esta...

Eligibility Criteria

Inclusion

  • 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 \< 3
  • Laboratory value requirements at enrollment:
  • Absolute neutrophil count \> 1500/mm³
  • Platelet count \> 100,000/mm³
  • Hemoglobin \> 8 g/dL
  • Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \< 2.5 x upper limit of normal (ULN) unless liver metastases documented. If so, AST and ALT \< 5 x ULN required.
  • Total bilirubin \< 1.5 x ULN, EXCEPT if Gilbert's syndrome is present. If so, total bilirubin \< 2.5 x ULN
  • Serum Creatinine \< 1.5 mg/dL OR an estimated creatinine clearance from 24 hour urine collection \> 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2011

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2019

    Estimated Enrollment :

    27 Patients enrolled

    Trial Details

    Trial ID

    NCT01437449

    Start Date

    October 1 2011

    End Date

    August 1 2019

    Last Update

    January 30 2024

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of California Davis Medical Center

    Davis, California, United States, 95616

    2

    Stanford University, School of Medicine

    Stanford, California, United States, 95305