Clinical trial NCT00258297: Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery
Official title: A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2005-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage I, stage II, or stage III esophageal cancer that can be removed by surgery.

Detailed description: 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.

Eligibility 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)

Primary outcomes:
measure: Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center at University of Rochester Medical Center
state: New York
Study officials:
affiliation: James P. Wilmot Cancer Center
name: Kishan J. Pandya, MD
role: STUDY_CHAIR
References: