Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery

Esophageal Cancer Clinical Trial

Official title:

A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00258297
• Other study ID #: CDR0000447159
• Secondary ID: URCC-U2203ZENECA
• Status: Terminated
• Phase: Phase 2
• First received: November 22, 2005
• Last updated: October 14, 2013
• Start date: April 2004
• Est. completion date: November 2006

Study information

• Verified date: October 2013
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• gefitinib

Procedure:
• conventional surgery

• enzyme inhibitor therapy

• neoadjuvant therapy

• protein tyrosine kinase inhibitor therapy

• surgery

Locations

Country	Name	City	State
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib