Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
NCT ID: NCT00352118
Last Updated: 2017-12-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2006-03-31
2008-04-30
Brief Summary
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PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.
Detailed Description
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Primary
* Determine feeding tube dependency at 12 months in patients with locally advanced head and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by cisplatin and reduced-dose radiotherapy.
Secondary
* Determine the progression-free, disease-free, and overall survival of patients treated with this regimen.
* Determine the pattern of failure in patients treated with this regimen.
* Evaluate the quality of life of patients treated with this regimen.
* Assess pre- and post-treatment swallowing ability of patients and the impact on their quality of life.
Tertiary
* Quantify salivary flow rates of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
* Evaluate the quality of saliva by examining total protein concentrations.
* Quantify proangiogenic cytokines (interleukin \[IL\]-1, IL-6, IL-8, and vascular endothelial growth factor) in the saliva of these patients.
* Determine the degree of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
* Compare salivary flow rates with the grade of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
OUTLINE: This is a pilot study.
* Induction therapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 followed by fluorouracil IV continuously on days 1- 4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 5-14 or pegfilgrastim SC on day 5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a partial or clinical complete response proceed to chemoradiotherapy 3 weeks later.
* Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent reduced-dose radiotherapy 5 days a week for 6 weeks.
* Surgery: Approximately 6 to 8 weeks after completing chemoradiotherapy, patients with residual neck disease or disease initially staged at N2 or greater undergo neck dissection.
Saliva is collected periodically to measure flow rates and quality; quantify proangiogenic cytokines (interleukin \[IL\]-1, IL-6, IL-8 and vascular endothelial growth factor); and examine the grade of mucositis and xerostomia.
Quality of life is assessed at baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year.
After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
filgrastim
subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.
pegfilgrastim
If applicable on day 5, repeating every 3 weeks for 2 courses.
cisplatin
Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.
docetaxel
Intravenous over 1 hour on day 1.
fluorouracil
Intravenous continuously on days 1-4.
conventional surgery
As appropriate, neck dissection.
radiation therapy
60 Gy 5 days/week x 6 weeks with cisplatin
Interventions
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filgrastim
subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.
pegfilgrastim
If applicable on day 5, repeating every 3 weeks for 2 courses.
cisplatin
Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.
docetaxel
Intravenous over 1 hour on day 1.
fluorouracil
Intravenous continuously on days 1-4.
conventional surgery
As appropriate, neck dissection.
radiation therapy
60 Gy 5 days/week x 6 weeks with cisplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage IVA or IVB disease
* Stage III disease allowed provided patient may benefit from organ preservation or patient refused surgery
* Measurable or evaluable disease
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min
* Bilirubin normal
* Alkaline phosphatase (AP) and AST or ALT must be within the following ranges:
* AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
* AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
* AP ≤ 5 times ULN AND AST or ALT normal
Exclusion Criteria
* Evidence of distant metastatic disease
* Pregnant or nursing
* Positive pregnancy test (Fertile patients must use effective contraception during study treatment and for 3 months after completion of study treatment)
* Other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage and nature of disease is such that it is unlikely to affect survival for the next 3 years
* Peripheral neuropathy ≥ grade 2
* Hearing loss ≥ grade 2
* Severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 and/or cisplatin or other platinum analogs
* Poor nutritional status, in the opinion of the investigator
* Active infection
* Active ischemic heart disease
* Myocardial infarction within the past 6 months
* Prior radiotherapy above the clavicles
* Prior chemotherapy
* Prior surgery to the primary tumor except biopsy
* Concurrent amifostine or other investigational agents
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Frank G. Ondrey, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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UMN-0502M67486
Identifier Type: -
Identifier Source: secondary_id
2005LS012
Identifier Type: -
Identifier Source: org_study_id