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(Withdrawn for lack of funding and accrual)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

November 22, 2005
October 14, 2013
April 2004
November 2006   (final data collection date for primary outcome measure)
Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib
Not Provided
Complete list of historical versions of study NCT00258297 on ClinicalTrials.gov Archive Site
Not Provided
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Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery
A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
  • Drug: gefitinib
  • Procedure: conventional surgery
  • Procedure: enzyme inhibitor therapy
  • Procedure: neoadjuvant therapy
  • Procedure: protein tyrosine kinase inhibitor therapy
  • Procedure: surgery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
November 2006
November 2006   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00258297
CDR0000447159, URCC-U2203, ZENECA-1839US/0282
Yes
University of Rochester
University of Rochester
Not Provided
Study Chair: Kishan J. Pandya, MD James P. Wilmot Cancer Center
University of Rochester
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP