Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent and/or metastatic head and neck cancer. Biological therapies such as gefitinib may interfere with the growth of tumor cells by blocking an enzyme necessary for cell growth.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Gefitinib

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary squamous cell cancer of the head and neck that is incurable by surgery or radiotherapy

• Stratum I:

• Failed surgery and/or radiotherapy and received no prior systemic chemotherapy for recurrent disease OR

• Recurrent disease at least 6 months after prior multimodal primary therapy including neoadjuvant or concurrent chemotherapy OR

• Metastatic disease at initial diagnosis and received no prior chemotherapy

• Stratum II:

• No more than 1 prior chemotherapy regimen for recurrent disease OR

• Recurrent disease within 6 months after prior primary therapy that included chemotherapy

• Measurable disease

• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

• Clear clinical evidence of progression or biopsy-proven residual cancer required if only site of measurable disease is in a previously irradiated field

• No known brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal (no greater than 1.5 times upper limit of normal [ULN] if liver metastases present)

• AST/ALT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Other:

• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No other uncontrolled concurrent illness

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study compliance

• No prior allergic reactions attributed to compounds of similar chemical or biologic composition to gefitinib

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior therapy with agents that target epidermal growth factor receptors

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

• No concurrent tamoxifen

Radiotherapy:

• Prior radiotherapy as primary or secondary treatment allowed

• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• Prior surgery as primary or secondary treatment allowed

• At least 4 weeks since prior major surgery

Other:

• No other concurrent investigational agents

• No concurrent combination antiretroviral therapy for HIV

• No concurrent 3A4 inhibitors (e.g., ketoconazole, erythromycin, verapamil)

• No concurrent drugs with known corneal toxicity (e.g., chlorpromazine, amiodarone, chloroquine)