Status:
COMPLETED
Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 f...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00083057
Start Date
May 1 2004
End Date
November 1 2010
Last Update
March 15 2012
Active Locations (2)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
2
NCI - Metabolism Branch;MET
Bethesda, Maryland, United States, 20892-1547