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

NCT00024089 | Completed Phase 2

• 3 other identifiers: CDR0000068890UUMC-8429-01NCI-1701
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Keywords

recurrent metastatic squamous neck cancer with occult primary; metastatic squamous neck cancer with occult primary squamous cell carcinoma; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; salivary gland squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease control rate

Secondary Outcomes (3)

• Biologic parameters

• Toxicity

• Response

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral gefitinib daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: gefitinib

Interventions

gefitinib DRUG

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Richard H. Wheeler, MD

  University of Utah

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Primary Completion: March 1, 2006
• Last Updated: February 11, 2013

Record last verified: 2005-11

Locations

US (1)