Phase 2 N=33 Treatment

Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer

Head and Neck Cancer · Cancer of the Pharynx · Cancer of the Larynx · Nose Neoplasms · Paranasal Sinus Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT00462735 ↗

Enrolled (actual)

Serious AEs

100.0%

Results posted

Mar 2018

Primary outcome: Primary: Llocoregional Recurrence — 27 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cetuximab (Drug); Hydroxyurea (Drug); Fluorouracil (Drug); radiotherapy (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johnny Kao
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Llocoregional Recurrence	27	—
PRIMARY Survival	86; 69	—
SECONDARY Long- Term Toxicity	32	—
SECONDARY UW-QOLR: Quality of Life Score	80	—
SECONDARY Distant Metastases	21	—

Summary

For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach may be needed for these patients to prevent recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of patients are cured with this strategy. While cure rates are higher than standard chemotherapy and radiation and the treatment is tolerable, side effects during treatment are common. We propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab. Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.

Eligibility Criteria

Inclusion Criteria

Age 18 years or older
Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck or lymphoepithelioma
No prior chemotherapy or radiotherapy
Prior surgical therapy will consist only of incisional or excisional biopsy, and organ sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an existing primary tumor
Karnofsky performance status of >= 70%
Intact organ and bone marrow function
Obtained informed consent

Exclusion Criteria

Demonstration of metastatic disease (i.e. M1 disease).
Patients with a history of severe allergic reaction to docetaxel or other drugs formulated with polysorbate 80. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, 5-fluorouracil, or hydroxyurea.
Other coexisting malignancies or malignancies diagnosed within the previous 3 years with the exception of basal cell carcinoma, cervical cancer in situ, and other treated malignancies with no evidence of disease for at least 3 years.
Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor. Any non-biopsy procedure must have taken place less than 3 months from initiating protocol treatment.
Incomplete healing from previous surgery
Pregnancy or breast feeding (men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary artery disease will be at the discretion of the attending physician.
Uncontrolled active infection unless curable with treatment of their cancer.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00462735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.