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INDUCTION CHEMOTHERAPY WITH DOCETAXEL, CISPLATIN, AND 5-FLUOROURACIL FOLLOWED BY CONCOMITANT CETUXIMAB AND RADIATION THERAPY FOR LOCOREGIONALLY ADVANCED SQUAMOUS CELL CANCER OF THE HEAD AND NECK: A PHASE II TRIAL


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

INDUCTION CHEMOTHERAPY WITH DOCETAXEL, CISPLATIN, AND 5-FLUOROURACIL FOLLOWED BY CONCOMITANT CETUXIMAB AND RADIATION THERAPY FOR LOCOREGIONALLY ADVANCED SQUAMOUS CELL CANCER OF THE HEAD AND NECK: A PHASE II TRIAL


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Organ Sparing Survival

Outcome Description:

to determine whether the intervention will prolong survival without needing salvage surgery (organ sparing survival)

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Rene R Rubin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Drexel University

Authority:

United States: Institutional Review Board

Study ID:

19834

NCT ID:

NCT01467115

Start Date:

March 2010

Completion Date:

June 2014

Related Keywords:

  • Head and Neck Cancer
  • loco regionally advanced
  • head and neck cancer
  • chemotherapy
  • radiation
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192