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

NCT ID: NCT00258297

Last Updated: 2013-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2006-11-30

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.

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

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

gefitinib

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

enzyme inhibitor therapy

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

protein tyrosine kinase inhibitor therapy

Intervention Type: PROCEDURE

surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kishan J. Pandya, MD

Role: STUDY_CHAIR

James P. Wilmot Cancer Center

Locations

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

URCC-U2203

Identifier Type: -

Identifier Source: secondary_id

ZENECA-1839US/0282

Identifier Type: -

Identifier Source: secondary_id

CDR0000447159

Identifier Type: -

Identifier Source: org_study_id