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NCT00410826 · REGISTRY CONDITION SEARCH

Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2013-05-10

This randomized phase II trial is studying cisplatin and radiation therapy together with or without erlotinib hydrochloride to compare how well they work in treating patients with stage III or stage IV head and neck cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Giving cisplatin and radiation therapy together with erlotinib hydrochloride may kill more tumor cells. It is not yet known whether cisplatin and radiation therapy are more effective with or without erlotinib hydrochloride in treating head and neck cancer

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm

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outcome · NOT POSTED

Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm

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outcome · POSTED

Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Cytological or pathological documented squamous cell carcinoma of oral cavity, oropharynx, larynx, and hypopharynx; patients with nasopharyngeal carcinoma can be included if the patients have grades I or II tumors according to the World Health Organization (WHO) classification * Stage III or IV according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, Sixth Edition (2002) * Unresectable or resection with significant morbidity * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Measurable Disease, defined according to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria * Bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 x ULN * Calculated creatinine clearance \>= 55ml/min (using the Cockcroft-Gault formula) * Platelet count \>= 100 x 10\^9 /L * Absolute neutrophil count (ANC) \>= 1.25 x 10\^9 /L * Signed informed consent * Male and female patients with reproductive potential must use an acceptable contraceptive method * Authorization from a dentist to begin radiation therapy Exclusion Criteria: * Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment * Inability or unwillingness to comply with radiotherapy * Evidence of clinically significant congestive heart failure; patients must be able to tolerate hydration required during cisplatin chemotherapy * Diarrhea \> grade 1 at the time of enrollment * Prior radiotherapy, chemotherapy, or investigational treatment for squamous cell carcinoma of head and neck * Prior treatment with an investigational or marketed inhibitor of the EGFR pathway * Use of cytochrome P450 3A4 (CYP3A4) inducers * Presence of systemic metastases (M1) * Pregnant or breast-feeding women * Known human immunodeficiency virus (HIV) infection
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47. Patients also receive erlotinib hydrochloride PO once daily on days -7 to 47.
    intervention Names
    1. Drug: erlotinib hydrochloride
    2. Drug: cisplatin
    3. Radiation: 3-dimensional conformal radiation therapy
    4. Radiation: intensity-modulated radiation therapy
    5. Procedure: quality-of-life assessment
    label
    Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer)
    type
    EXPERIMENTAL
  2. description
    Patients receive cisplatin and radiotherapy as in Arm I.
    intervention Names
    1. Drug: cisplatin
    2. Radiation: 3-dimensional conformal radiation therapy
    3. Radiation: intensity-modulated radiation therapy
    4. Procedure: quality-of-life assessment
    label
    Arm II (chemotherapy, radiotherapy)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer)
    description
    Given orally
    name
    erlotinib hydrochloride
    other Names
    1. CP-358,774
    2. erlotinib
    3. OSI-774
    type
    DRUG
  2. arm Group Labels
    1. Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer)
    2. Arm II (chemotherapy, radiotherapy)
    description
    Given IV
    name
    cisplatin
    other Names
    1. CACP
    2. CDDP
    3. CPDD
    4. DDP
    type
    DRUG
  3. arm Group Labels
    1. Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer)
    2. Arm II (chemotherapy, radiotherapy)
    description
    35 fractions
    name
    3-dimensional conformal radiation therapy
    other Names
    1. 3D-CRT
    2. conformal radiation therapy
    type
    RADIATION
  4. arm Group Labels
    1. Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer)
    2. Arm II (chemotherapy, radiotherapy)
    description
    35 fractions
    name
    intensity-modulated radiation therapy
    other Names
    1. IMRT
    type
    RADIATION
  5. arm Group Labels
    1. Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer)
    2. Arm II (chemotherapy, radiotherapy)
    description
    Ancillary studies
    name
    quality-of-life assessment
    other Names
    1. quality of life assessment
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
204
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).
    measure
    Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm
    time Frame
    12 weeks after the completion of therapy
secondary Outcomes
  1. measure
    Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm
    time Frame
    30 days after the completion of therapy
  2. description
    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
    measure
    Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride
    time Frame
    Every 3 months for up to 5 years
Full study description
brief Summary
This randomized phase II trial is studying cisplatin and radiation therapy together with or without erlotinib hydrochloride to compare how well they work in treating patients with stage III or stage IV head and neck cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Giving cisplatin and radiation therapy together with erlotinib hydrochloride may kill more tumor cells. It is not yet known whether cisplatin and radiation therapy are more effective with or without erlotinib hydrochloride in treating head and neck cancer
detailed Description
PRIMARY OBJECTIVES: I. Compare the complete response rate in patients with locally advanced head and neck cancer, treated with cisplatin, radiotherapy and erlotinib (erlotinib hydrochloride) versus cisplatin and radiotherapy alone. SECONDARY OBJECTIVES: I. Evaluate whether the addition of erlotinib increases the acute and long term toxicities of cisplatin and radiotherapy, in patients with locally advanced head and neck cancer. II. Compare the disease-free and overall survivals of patients with locally advanced head and neck cancer treated with cisplatin and radiotherapy, with and without erlotinib. III. Evaluate whether the symptomatic improvement observed in the first week of erlotinib alone predicts for complete response and long term disease control. IV. Correlate epidermal growth factor receptor (EGFR), p16 and excision repair cross-complementing 1 (ERCC-1) expression with response outcome to therapy with cisplatin and radiation with and without erlotinib. V. Identify other molecular correlates that may be relevant in the pathogenesis of squamous cell carcinoma of head and neck (SCCHN) or response to therapy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cisplatin intravenously (IV) on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47. Patients also receive erlotinib hydrochloride orally (PO) once daily (QD) on days -7 to 47. ARM II: Patients receive cisplatin and undergo radiotherapy as in Arm I. Within 10-14 weeks after completion of study treatment, patients with N2 or N3 disease at the time of screening undergo a neck dissection. After completion of study treatment, patients are followed up periodically for 5 years.
Source references
references
  1. citation
    Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.
    pmid
    25057165
    type
    DERIVED
  2. citation
    Bauman JE, Austin MC, Schmidt R, Kurland BF, Vaezi A, Hayes DN, Mendez E, Parvathaneni U, Chai X, Sampath S, Martins RG. ERCC1 is a prognostic biomarker in locally advanced head and neck cancer: results from a randomised, phase II trial. Br J Cancer. 2013 Oct 15;109(8):2096-105. doi: 10.1038/bjc.2013.576. Epub 2013 Sep 24.
    pmid
    24064970
    type
    DERIVED
  3. citation
    Martins RG, Parvathaneni U, Bauman JE, Sharma AK, Raez LE, Papagikos MA, Yunus F, Kurland BF, Eaton KD, Liao JJ, Mendez E, Futran N, Wang DX, Chai X, Wallace SG, Austin M, Schmidt R, Hayes DN. Cisplatin and radiotherapy with or without erlotinib in locally advanced squamous cell carcinoma of the head and neck: a randomized phase II trial. J Clin Oncol. 2013 Apr 10;31(11):1415-21. doi: 10.1200/JCO.2012.46.3299. Epub 2013 Mar 4.
    pmid
    23460709
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice