Head and Neck Cancer Clinical Trial
— DREXNECKOfficial 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
Verified date | May 2017 |
Source | Drexel University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1 |
Est. completion date | October 7, 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Hahnemann University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Drexel University College of Medicine |
United States,
Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. — View Citation
De Boer MF, McCormick LK, Pruyn JF, Ryckman RM, van den Borne BW. Physical and psychosocial correlates of head and neck cancer: a review of the literature. Otolaryngol Head Neck Surg. 1999 Mar;120(3):427-36. Review. — View Citation
Department of Veterans Affairs Laryngeal Cancer Study Group, Wolf GT, Fisher SG, Hong WK, Hillman R, Spaulding M, Laramore GE, Endicott JW, McClatchey K, Henderson WG. Induction chemotherapy plus radiation compared with surgery plus radiation in patients with advanced laryngeal cancer. N Engl J Med. 1991 Jun 13;324(24):1685-90. — View Citation
Deshmane VH, Parikh HK, Pinni S, Parikh DM, Rao RS. Laryngectomy: a quality of life assessment. Indian J Cancer. 1995 Sep;32(3):121-30. — View Citation
Haddad RI, Shin DM. Recent advances in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1143-54. doi: 10.1056/NEJMra0707975. — View Citation
Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20. — View Citation
Paccagnella A, Orlando A, Marchiori C, Zorat PL, Cavaniglia G, Sileni VC, Jirillo A, Tomio L, Fila G, Fede A, et al. Phase III trial of initial chemotherapy in stage III or IV head and neck cancers: a study by the Gruppo di Studio sui Tumori della Testa e del Collo. J Natl Cancer Inst. 1994 Feb 16;86(4):265-72. — View Citation
Zorat PL, Paccagnella A, Cavaniglia G, Loreggian L, Gava A, Mione CA, Boldrin F, Marchiori C, Lunghi F, Fede A, Bordin A, Da Mosto MC, Sileni VC, Orlando A, Jirillo A, Tomio L, Pappagallo GL, Ghi MG. Randomized phase III trial of neoadjuvant chemotherapy in head and neck cancer: 10-year follow-up. J Natl Cancer Inst. 2004 Nov 17;96(22):1714-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Organ Sparing Survival | to determine whether the intervention will prolong survival without needing salvage surgery (organ sparing survival) | 3 years | |
Secondary | Overall Survival | we will determine if the intervention prolongs overall survival. | 3 years |
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