Head and Neck Cancer Clinical Trial
Official title:
A Pilot Phase I Dose Escalation Study Of The EGFR Tyrosine Kinase Inhibitor Gefitinib (Iressa) Combined With Paclitaxel (Taxol) And External Beam Radiation Therapy In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck (SCCHN)
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary
for their growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to
stop tumor cells from dividing so they stop growing or die. Radiation therapy uses
high-energy x-rays to damage tumor cells. Giving gefitinib and paclitaxel together with
radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib and
paclitaxel when given together with radiation therapy in treating patients with advanced or
recurrent squamous cell carcinoma (cancer) of the head and neck.
Status | Completed |
Enrollment | 30 |
Est. completion date | November 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell (epidermoid) carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, or maxillary sinus - Stage III or IV disease - Distant metastases allowed provided both of the following are true: - Metastases are confined to the head and neck region - Metastases are encompassable in a radiotherapy field with curative intent - Locally recurrent disease after primary surgery allowed - Meets 1 of the following criteria: - Unresectable disease - Patient prefers chemoradiotherapy over surgery - Measurable disease - No brain metastases and/or carcinomatous meningitis PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - WBC = 3,000/mm^3 - Hemoglobin > 10 g/dL - Platelet count > 100,000/mm^3 - Absolute neutrophil count = 1,500/mm^3 Hepatic - Bilirubin < 2.0 times upper limit of normal (ULN) - AST/ALT = 2.5 times ULN Renal - Creatinine < 1.5 times ULN OR - Creatinine clearance = 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary - No clinically active interstitial lung disease - Chronic, stable, asymptomatic radiographic changes allowed Other - No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs or Cremophor^® EL - No AIDS or primary immunodeficiencies - No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix - Probability of recurrence of the prior malignancy < 5% - No other concurrent uncontrolled illness - No ongoing or active serious infection - No psychiatric illness or situation that would preclude study compliance or giving informed consent - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for cancer - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior therapeutic radiotherapy to the head and neck region - No prior radiotherapy for cancer Surgery - See Disease Characteristics - At least 4 weeks since prior major surgery and recovered Other - No prior gefitinib or other epidermal growth factor receptor inhibitors - More than 4 weeks since prior non-approved or investigational agents - No concurrent administration of any of the following: - Phenytoin - Carbamazepine - Barbiturates - Rifampin - Hypericum perforatum (St. John's wort) - Oxcarbazepine - Rifapentine - Amifostine - Modafinil - Other CYP3A4 enzyme inducers - Other anticancer agents or investigational drugs - Combination antiretroviral therapy for HIV-positive patients |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | NCI - Metabolism Branch;MET | Bethesda | Maryland |
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) | National Cancer Institute (NCI) |
United States,
Sharp H, Morris JC, Van Waes C, Gius D, Cooley-Zgela T, Singh AK. High incidence of oral dysesthesias on a trial of gefitinib, Paclitaxel, and concurrent external beam radiation for locally advanced head and neck cancers. Am J Clin Oncol. 2008 Dec;31(6):5 — View Citation
Sharp HJ, Morris JC, Van Waes C, et al.: A high incidence of oral dysesthesias unrelated to mucositis in a pilot trial of gefitinib, paclitaxel and concurrent external beam radiation in patients with locally advanced squamous cell carcinoma of the head an
Van Waes C, Allen CT, Citrin D, Gius D, Colevas AD, Harold NA, Rudy S, Nottingham L, Muir C, Chen Z, Singh AK, Dancey J, Morris JC. Molecular and clinical responses in a pilot study of gefitinib with paclitaxel and radiation in locally advanced head-and-n — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) as assessed by CTC v. 3.0 | Yes | ||
Secondary | Molecular targets analysis of epidermal growth factor receptor (EGFR) downstream signaling pathway as assessed by tissue biopsies and serum cytokines at baseline, days 8 and 29, and 12 weeks after completion of study treatment | No | ||
Secondary | Efficacy as assessed by imagining, histologically, and clinically at 3 months after completion of study treatment and annually for 5 years | No |
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