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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.
 
ClinicalTrials.gov Identifier: NCT01437449
Recruitment Status : Completed
First Posted : September 20, 2011
Results First Posted : December 17, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
A. Dimitrios Colevas, Stanford University

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 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.

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

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 establish the safety profile, progression free and overall survival of weekly TPC in this patient population.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
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
Actual Primary Completion Date : September 11, 2018
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: Cisplatin + Docetaxel + Cetuximab
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
Drug: Docetaxel
30 mg/m² by intravenous (IV) administration
Other Name: Taxotere

Drug: Cisplatin
30 mg/m² by intravenous (IV) administration
Other Names:
  • Cisplatinum
  • Platinol

Drug: Cetuximab
400 mg/m² by intravenous (IV) administration, thereafter 250 IV
Other Name: Erbitux

Drug: Carboplatin
Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
Other Name: Paraplatin




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 8 weeks ]

    Clinical response for each participant will be assessed after 8 weeks of treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Overall response rate (ORR) was assessed as the sum of the number of participants that experience a complete response (CR) or partial response (PR). The outcome is defined and reported as the number of subjects that responded, a number without dispersion. Other response statuses are included. RECIST v1.1 criteria is defined as follows.

    • Complete Response (CR) = Disappearance of all target lesions
    • Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions
    • Overall Response (OR) = CR + PR
    • Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
    • Stable disease (SD) = Small changes that do not meet any of the above criteria


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 24 months ]

    Progression-free survival (PFS), defined as the duration of time from start of treatment to time of progression or death, was assessed through 24 months, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. The outcome is reported as the median time that participants remained free of progression, with 95% confidence interval (CI).

    • Complete Response (CR) = Disappearance of all target lesions
    • Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions
    • Overall Response (OR) = CR + PR
    • Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
    • Stable disease (SD) = Small changes that do not meet any of the above criteria

  2. Overall Survival (OS) [ Time Frame: 24 months ]
    Overall survival (OS) was assessed through 24 months. The outcome is reported as the median time that participants remained alive, with 95% CI.

  3. Grade 3, 4, and 5 Related Adverse Events (Toxicities) [ Time Frame: 2 years ]
    Related adverse events are considered toxicities. The outcome was assessed as adverse events and serious adverse events (SAEs per 21CFR§312.32) at least Grade 3, and are reported as the number of toxicities by grade (3, 4 or 5), a number without dispersion.



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

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 ClinicalTrials.gov identifier (NCT number): NCT01437449


Locations
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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
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Principal Investigator: A. Dimitrios Colevas, MD Stanford University
  Study Documents (Full-Text)

Documents provided by A. Dimitrios Colevas, Stanford University:
Informed Consent Form  [PDF] August 23, 2016

Publications of Results:
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Responsible Party: A. Dimitrios Colevas, Professor of Medicine (Oncology) and Otolaryngology, Stanford University
ClinicalTrials.gov Identifier: NCT01437449    
Other Study ID Numbers: IRB-22329
SU-08222011-8290 ( Other Identifier: Stanford University Medical Center )
NCI-2011-03271 ( Other Identifier: CTRP )
ENT0033 ( Other Identifier: OnCore )
First Posted: September 20, 2011    Key Record Dates
Results First Posted: December 17, 2019
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by A. Dimitrios Colevas, Stanford University:
Quality of Life
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Carboplatin
Docetaxel
Cetuximab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological