Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00258297
NCT00258297TerminatedPhase 2

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

University of Rochester2 sites in 1 country30 target enrollmentStarted: April 2004Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
30
Locations
2
Primary Endpoint
Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Terminated
Phase 1
Gefitinib, Cisplatin, Irinotecan, and Radiation Therapy Before Surgery in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By SurgeryEsophageal Cancer
NCT00290719University of California, San Francisco6
Withdrawn
Phase 1
Gefitinib and Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung CancerNon-small Cell Lung Cancer
NCT00268255Barbara Ann Karmanos Cancer Institute
Unknown
Phase 2
Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung CancerLung Cancer
NCT00616499Yonsei University35
Completed
Phase 2
Gefitinib in Treating Patients With Previously Untreated Stage IIIB or Stage IV Non-Small Cell Lung CancerLung Cancer
NCT00411047Massachusetts General Hospital34
Completed
Phase 2
Gefitinib in Treating Patients With Locally Advanced Esophageal CancerEsophageal Cancer
NCT00100945Alliance for Clinical Trials in Oncology70
Gefitinib in Treating Patients With Stage... | Clinical Trial