Clinical trial NCT01467115: Induction Chemotherapy Followed by Cetuximab and Radiation Therapy for Head and Neck Cancer
Official title: Induction Chemotherapy With Taxotere, Cisplatin and 5-Fluorouracil Followed by Concomitant Cetuximab and Radiation for Locoregionally Advanced Squamous Cell Cancer of the Head and Neck: A Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: loco regionally advanced
head and neck cancer
chemotherapy
radiation
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: More than 50% of Head and Neck cancers are locally advanced at presentation. Although surgery, in combination with other modalities like radiation therapy can achieve 40-50% five year survival rates, resection in the head and neck region can leave patients with poor functional and cosmetic outcomes.

Due to these concerns about quality of life after surgery, there has been a lot of interest in non surgical alternatives of treatment. Various combinations of radiation, chemotherapy and biologics has showed promising results. However, questions still remain about the ideal combination treatment regimen.

Based on assimilation of data from multiple sources, our study tries to identify the role of a potentially highly effective multi-modality regimen based on induction chemotherapy (Cisplatin, Docetaxel and 5 Fluorouracil) followed by combination of a biologic agent, Cetuximab, and radiation therapy.

Detailed description: Patients will be given two cycles of induction chemotherapy with Cisplatin, Docetaxel and Fluorouracil. This will be followed by six weeks of radiation therapy along with Cetuximab. Patients will get two more cycles of chemotherapy with the same agents after the completion of radiation therapy course. Patients will be watched very closely during the trial period, with close follow up of treatment responses and monitoring of any adverse effects.

Eligibility criteria: INCLUSION CRITERIA

* Biopsy and/or fine needle aspirate of the tumor is required prior to registration. Pathologically confirmed primary squamous cell cancer of the oral cavity, oropharynx, hypopharynx, larynx, or unknown primary confined to the head and neck; histological variants such as spindle cell carcinoma, poorly differentiated keratin-positive carcinoma, and lymphoepithelioma are included. Patients with nasopharyngeal and salivary gland tumors are ineligible.
* Measureable disease representing stage III or stage IVa or IVb cancer by AJCC staging is required (See Appendix II)
* Measureable disease representing stage II cancer qualifies if the patient refuses surgery or is unable to undergo surgery as curative treatment
* Patient must not have had previous irradiation or surgery other than biopsy of the head and neck region
* A CT of the chest and CT or MRI of the tumor site is required within four weeks prior to registration
* Appropriate staging evaluation is required within four weeks prior to registration, including the following:
* history and physical examination with special attention to functional status measures, carotid arteries, neck and clavicular lymph nodes
* chest CT with evaluation of any nodules ≥ 1cm with biopsy or PET/CT (patients with lesions \< 1cm, negative on PET scan, or that cannot be safely biopsied remain eligible).
* ECOG performance status 0-2 (See Appendix III)
* Age ≥ 18 years
* Complete blood count evaluation within two weeks of treatment demonstrating absolute neutrophil count ≥ 1500/mm3, platelets ≥100,000 cells/mm3, and hemoglobin ≥ 8g/dL
* Liver function tests within two weeks of treatment demonstrating total bilirubin ≤1.5 mg/dL, AST and ALT \< 2x upper limit of normal, and alkaline phosphatase \< 2x upper limits of normal; an abdominal CT scan is required if any of the above criteria are not met
* Adequate renal function measured within two weeks of treatment, defined as a creatinine clearance ≥ 50 ml/min determined by a 24 hour urine creatinine or the Cockcroft-Gault equation, where creatinine clearance (ml/min) is equal to:

\[(140 - age) x (wt in kg)\] x 0.85 for females \[(sCR) x (72)\]

* Corrected serum calcium \<11 mg/dL within two weeks prior to treatment.
* Urine pregnancy test two weeks prior to treatment for women of childbearing potential; women of childbearing potential and male participants must agree to use a medically effective means of contraception throughout the duration of treatment and 30 days thereafter
* All patients must sign study-specific informed consent prior to study entry.

EXCLUSION CRITERIA:

* Evidence of metastatic disease
* Prior head and neck cancer.
* History of invasive cancer of any primary sight not considered cured.
* Previous radiation to the head and neck
* Nasopharyngeal or salivary gland cancer
* Severe, active comorbidity, defined as:
* New York Heart Association Class III or IV heart failure (Appendix IV)
* Unstable angina
* Acute bacterial or fungal infection requiring antibiotic treatment
* Chronic obstructive pulmonary disease requiring long term oral steroids or hospitalization for exacerbation within three months of study registration
* Liver dysfunction resulting in clinical jaundice or coagulation defects
* Acquired Immune Deficiency Syndrome defined as CD4 count \<200 or opportunistic AIDS defining infection requiring active antibiotic treatment
* Pregnancy, lactation, or refusal of patient to take appropriate medical or behavioral measures to prevent pregnancy
* Pre-existing peripheral neuropathy \> grade 2
* Hypersensitivity reaction to any drug listed in the protocol

Primary outcomes:
measure: Organ Sparing Survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Rene R Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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