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

Primary Purpose

Esophageal Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gefitinib
conventional surgery
enzyme inhibitor therapy
neoadjuvant therapy
protein tyrosine kinase inhibitor therapy
surgery
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Outcomes

Primary Outcome Measures

Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib

Secondary Outcome Measures

Full Information

First Posted
November 22, 2005
Last Updated
October 14, 2013
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT00258297
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Withdrawn for lack of funding and accrual
Study Start Date
April 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gefitinib
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
enzyme inhibitor therapy
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
protein tyrosine kinase inhibitor therapy
Intervention Type
Procedure
Intervention Name(s)
surgery
Primary Outcome Measure Information:
Title
Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kishan J. Pandya, MD
Organizational Affiliation
James P. Wilmot Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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

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