Phase 2 Completed N=60 Treatment

Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer

Source: ClinicalTrials.gov NCT00352105 ↗

Enrolled (actual)

Serious AEs

100.0%

Results posted

Mar 2012

Primary outcomePrimary: Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival — 52 participants

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and gefitinib together with radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin, fluorouracil, and gefitinib together with hyperfractionated radiation therapy and to see how well they work in treating patients with locally advanced head and neck cancer.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival	52	—
PRIMARY Number of Participants With No Distant Metastatic Disease at 1 Year	54	—
SECONDARY Number of Participants With No Local Disease at 1 Year	48	—
SECONDARY Number of Patients With Greater Than or Equal to Mild (Grade 1) Toxicity	60	—
SECONDARY Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.	42	—
SECONDARY Number of Participants Who Completed 2 Years of Therapy	20	—

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary* squamous cell carcinoma of the head and neck region, excluding any of the following:
Nasopharynx
Paranasal sinuses
Salivary glands NOTE: *Primary site must be identified
Locoregionally confined stage III or IV disease
No evidence of nodal disease below the clavicles
No distant hematogenous metastases (M0)

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
WBC > 3,500/mm³
Platelet count > 100,000/mm³
Creatinine ≤ 2.0 mg/dL
Alkaline phosphatase < 2 times normal
AST < 2 times normal
Bilirubin ≤ 2.0 mg/dL
Calcium normal
Not pregnant or nursing
Fertile patients must use effective contraception
Must not be a poor compliance risk for follow-up
No known severe hypersensitivity to gefitinib or any excipients of this drug
No evidence of clinically active interstitial lung disease
Patients with chronic, stable radiographic changes who are asymptomatic are eligible
No unstable or uncontrolled angina, clinically apparent jaundice, or active infection
No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ) unless disease free for ≥ 5 years
No other severe, uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

PRIOR CONCURRENT THERAPY:

Recovered from prior oncologic or other major surgery
No prior definitive surgery, radiotherapy, chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for head and neck cancer
No investigational drugs within the past 30 days
No concurrent CYP3A4 inducers, including any of the following:
Phenytoin
Carbamazepine
Rifampin
Phenobarbital
Hypericum perforatum (St. John's wort)
Concurrent surgery allowed provided gefitinib is not administered 2 weeks before and 2 weeks after surgery
No concurrent aminoglycoside antibiotics

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00352105). 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. Informational only — not medical advice.