NCT00084318 · REGISTRY CONDITION SEARCH

Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck

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: 2018-12-12

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab given together with chemoradiotherapy using docetaxel in treating patients with resected stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and neck.

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

Disease-free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Treatment Tolerance

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outcome · POSTED

Frequency of Toxicity (Grade 5 and Acute Non-hematologic Grade 4)

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outcome · POSTED

Frequency of Other Acute and Late Toxicity

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outcome · POSTED

Local-regional Control

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outcome · POSTED

Correlation of EGFR (Total and Phosphorylated) pMAPK, pAKT, Stat-3, KI-67, COX-2, and Cyclin B1 Expression With Local-regional Control, and Overall and Disease-free Survival

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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: DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck meeting the following criteria: * Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding lip, nasopharynx, or sinuses) * Gross total resection must be completed within 7 weeks of randomization, with pathology demonstrating one or more of the following risk factors: * Histologic extracapsular nodal extension * Histologic involvement of ≥ 2 regional lymph nodes * Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual. * Tonsillar cancer patients who undergo transoral excision of all gross tumor are eligible provided extracapsular nodal extension or involvement of ≥ 2 regional lymph nodes is histologically confirmed * American Joint Committee on Cancer (AJCC) pathological stage III or IV * No evidence of distant metastases * No synchronous or concurrent head and neck primary tumors PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin \> 8.0 g/dL Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), and alkaline phosphatase meeting 1 of the following parameters: * Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN * Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * No unstable angina * No uncontrolled hypertension * No myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass surgery or percutaneous transluminal coronary angioplasty) * No uncontrolled arrhythmia * No congestive heart failure * No more than 2 heart-related hospitalizations within the past year * No other active cardiac disease Pulmonary * No more than 2 hospitalizations for chronic obstructive pulmonary disease within the past year Neurologic * No pre-existing peripheral neuropathy ≥ grade 2 * No uncontrolled seizure disorder * No active neurological disease Other * No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No other invasive malignancy within the past 3 years except nonmelanoma skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No prior anti-epidermal growth factor receptor antibody therapy Chemotherapy * More than 3 years since prior cytotoxic chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior head and neck radiotherapy Surgery * See Disease Characteristics Other * No prior tyrosine kinase inhibitor therapy
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
intervention Names
Biological: cetuximab
Drug: cisplatin
Radiation: radiation therapy
label
RT + cisplatin + cetuximab
type
EXPERIMENTAL
description
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
intervention Names
Biological: cetuximab
Drug: docetaxel
Radiation: radiation therapy
label
RT + docetaxel + cetuximab
type
EXPERIMENTAL

interventions

arm Group Labels
RT + cisplatin + cetuximab
RT + docetaxel + cetuximab
description
400 mg/m\^2 intravenously over 120 minutes on day 1 (week 1) followed by 250 mg/m\^2 intravenously over 60 minutes in weeks 2 through 7.
name
cetuximab
type
BIOLOGICAL
arm Group Labels
RT + cisplatin + cetuximab
description
30 mg/m\^2 intravenously infused over over 60 minutes in weeks 2 through 7.
name
cisplatin
type
DRUG
arm Group Labels
RT + docetaxel + cetuximab
description
15 mg/m\^2 intravenously infused over 30 minutes in weeks 2 through 7.
name
docetaxel
type
DRUG
arm Group Labels
RT + cisplatin + cetuximab
RT + docetaxel + cetuximab
description
60 Gy (2 Gy once a day, 5 times a week)
name
radiation therapy
type
RADIATION

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 238
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Two-year rates are shown (Kaplan-Meier estimates). Disease-free survival is defined as the time from randomization to local, regional, or distant progression, second primary, or death (event) or last follow-up (censored). Response criteria as follows: No evidence of disease (NED): All patients must have no measurable tumor following surgery; Local-Regional Relapse: Recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; biopsy confirmation is necessary; Distant Relapse: Clear evidence of distant metastases (lung, bone, brain, etc.); Biopsy is recommended where possible. A solitary lung mass/nodule is considered a second primary neoplasm unless proven otherwise.
measure
Disease-free Survival
time Frame
From randomization to 2 years

secondary Outcomes

description
Two-year rates are shown (Kaplan-Meier estimates). Overall survival is defined as the time from randomization to death (event) or last follow-up (censored).
measure
Overall Survival
time Frame
From randomization to 2 years
description
Tolerability was defined as having received 90% of the radiation dose, 95% of the cetuximab loading dose, and at least 4 weeks of cetuximab and cisplatin or docetaxel at doses 95% of the protocol prescription. The percentage of patients determined to be tolerant of treatment are shown.
measure
Treatment Tolerance
time Frame
From start of treatment to end of treatment (protocol treatment lasts seven weeks).
description
Each regimen was monitored for excessive acute toxicity (defined as nonhematologic grade 4 toxicity within 90 days of the start of radiation or any grade 5 toxicity). The target rate was based on the observed rate from RTOG-9501/NCT00002670 of 15%. The unacceptable rate was \>30%. \[RTOG = Radiation Therapy Oncology Group\]
measure
Frequency of Toxicity (Grade 5 and Acute Non-hematologic Grade 4)
time Frame
From start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.
description
Maximum grade toxicity that is definitely, probably, or possibly related to protocol treatment.
measure
Frequency of Other Acute and Late Toxicity
time Frame
From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.
description
Two-year rate is shown (cumulative incidence estimate). Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).
measure
Local-regional Control
time Frame
From randomization to 2 years
measure
Correlation of EGFR (Total and Phosphorylated) pMAPK, pAKT, Stat-3, KI-67, COX-2, and Cyclin B1 Expression With Local-regional Control, and Overall and Disease-free Survival
time Frame
From randomization to two years

Full study description

brief Summary: RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab given together with chemoradiotherapy using docetaxel in treating patients with resected stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and neck.
detailed Description: OBJECTIVES: Primary * Compare disease-free survival of patients with resected stage III or IV squamous cell carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in combination with chemoradiotherapy comprising docetaxel vs cisplatin. Secondary * Compare the safety and efficacy of these regimens in these patients. * Compare locoregional control and overall survival rates in patients treated with these regimens. * Correlate epidermal growth factor receptor (total and phosphorylated), pMAPK, pAKT, Stat-3, Ki-67, cyclo-oxygenase-2, and cyclin B1 expression with outcome in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1), risk category (positive margins vs high risk \[i.e., ≥ 2 positive nodes or extracapsular nodal extension\]) and use of intensity-modulated radiotherapy (no vs yes). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive cetuximab IV over 2 hours on day 1 (week 1). Patients then receive cetuximab IV over 1 hour and cisplatin IV over 1 hour before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7). Patients undergo radiotherapy once daily, 5 days a week, beginning on day 8 for a total of 6 weeks (weeks 2-7). * Arm II: Patients receive cetuximab and undergo radiotherapy as in arm I. Patients also receive docetaxel IV over 30 minutes before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7). Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 4 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within approximately 29 months.

Source references

references

citation
Harari PM, Harris J, Kies MS, et al.: Phase II randomized trial of surgery followed by chemoradiation plus cetuximab for high-risk squamous cell carcinoma of the head and neck (RTOG 0234). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-22, S13, 2007.
type
RESULT
citation
Harari PM, Harris J, Kies MS, Myers JN, Jordan RC, Gillison ML, Foote RL, Machtay M, Rotman M, Khuntia D, Straube W, Zhang Q, Ang K. Postoperative chemoradiotherapy and cetuximab for high-risk squamous cell carcinoma of the head and neck: Radiation Therapy Oncology Group RTOG-0234. J Clin Oncol. 2014 Aug 10;32(23):2486-95. doi: 10.1200/JCO.2013.53.9163. Epub 2014 Jul 7.
pmid
25002723
type
RESULT

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice