Completed

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)

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What is being tested

Data Collection

Who is being recruted

Squamous Cell Carcinoma of Head and Neck+6

+ Carcinoma

+ Carcinoma, Squamous Cell

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the dose-limiting toxicity, toxicity profile, and maximum tolerated dose (MTD) of gefitinib and paclitaxel administered with radiotherapy in patients with advanced or recurrent squamous cell carcinoma of the head and neck. Secondary * Determine the efficacy of this regimen in patients treated at the MTD. OUTLINE: This is a pilot, dose-escalation study of gefitinib and paclitaxel. Patients receive oral gefitinib once daily beginning on day 1 and continuing until completion of radiotherapy. Patients receive paclitaxel IV over 1 hour on days 8, 15, 22, 29, 36, and 43 and undergo radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, 43-47, 50-54, and 57-61. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gefitinib and paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A cohort of 6 additional patients receive treatment at the MTD. Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 3 months for 3 years. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 2 years.

Official TitleA 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) 
NCT00080249NCT00083057
Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Squamous Cell Carcinoma of Head and NeckCarcinomaCarcinoma, Squamous CellHead and Neck NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialNeoplasms, Squamous Cell

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, United StatesSee the location
Suspended

NCI - Metabolism Branch;MET

Bethesda, United States
Completed2 Study Centers