A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer
18 Years
N/A
Both
Esophageal Cancer
Trial Information
A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer
OBJECTIVES:
Primary
- Determine the safety and tolerability of neoadjuvant gefitinib in patients with
resectable stage I-III esophageal cancer.
Secondary
- Determine the epidermal growth factor-receptor expression in tissue samples obtained at
diagnosis and surgery from patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral gefitinib once daily beginning between days -21 and -14 and continuing
until day -1. Patients undergo tumor resection on day 0.
After completion of study treatment, patients are followed periodically for 6 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell or adenocarcinoma of the thoracic esophagus
- Resectable, localized disease with or without metastases in local lymph nodes
(T1, T2, or T3; any N; M0)
- Stage I-III disease
- No known distant metastases
- No cervical-esophageal tumors (upper border < 18 cm from the incisor teeth)
- No supraclavicular metastases
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Adequate bone marrow function
Hepatic
- Adequate hepatic function
- No unstable or uncompensated hepatic disease
Renal
- Creatinine ≤ grade 2 by Common Toxicity Criteria
- Adequate renal function
- No unstable or uncompensated renal disease
Cardiovascular
- No unstable or uncompensated cardiac disease
Pulmonary
- No clinically active interstitial lung disease unless it is asymptomatic with chronic
stable radiographic changes
- No unstable or uncompensated respiratory disease
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No known hypersensitivity to gefitinib or any of the excipients
- No other malignancy within the past 2 years except basal cell carcinoma or carcinoma
in situ of the cervix
- No evidence of severe or uncontrolled systemic disease
- No other significant clinical disorder or laboratory finding that would preclude
study participation
PRIOR CONCURRENT THERAPY:
Endocrine therapy
- Concurrent stable-dose steroids allowed
Surgery
- Recovered from any prior oncologic or other major surgery
Other
- More than 30 days since prior nonapproved or investigational drug
- No prior therapy for this or any other malignancy
- No concurrent phenytoin, carbamazepine, barbiturates, rifampin, or Hypericum
perforatum (St. John's wort)
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib
Principal Investigator
Kishan J. Pandya, MD
Investigator Role:
Study Chair
Investigator Affiliation:
James P. Wilmot Cancer Center
Authority:
Unspecified
Study ID:
CDR0000447159
NCT ID:
NCT00258297
Start Date:
Completion Date:
Related Keywords:
- Esophageal Cancer
- stage I esophageal cancer
- stage II esophageal cancer
- stage III esophageal cancer
- adenocarcinoma of the esophagus
- squamous cell carcinoma of the esophagus
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
