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

This study has been terminated.
(Withdrawn for lack of funding and accrual)
Sponsor:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00258297
First received: November 22, 2005
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Drug: gefitinib
Procedure: conventional surgery
Procedure: enzyme inhibitor therapy
Procedure: neoadjuvant therapy
Procedure: protein tyrosine kinase inhibitor therapy
Procedure: surgery
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib

Estimated Enrollment: 30
Study Start Date: April 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258297

Locations
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Study Chair: Kishan J. Pandya, MD James P. Wilmot Cancer Center
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00258297     History of Changes
Other Study ID Numbers: CDR0000447159, URCC-U2203, ZENECA-1839US/0282
Study First Received: November 22, 2005
Last Updated: October 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gefitinib
Enzyme Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014