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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00268346 |
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with recurrent or metastatic esophageal or gastroesophageal junction cancer.
Condition | Intervention | Phase |
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Esophageal Cancer |
Drug: gefitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of ZD1839 (IRESSA®) for Patients With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction |
Estimated Enrollment: | 76 |
Study Start Date: | October 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to prior treatment (yes vs no).
Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed squamous cell carcinoma, adenocarcinoma, or large-cell undifferentiated carcinoma of the esophagus or gastroesophageal junction
Disease must be measurable in at least one dimension by physical exam, x-ray, CT scan or MRI, ultrasound, or endoscopy
PATIENT CHARACTERISTICS:
No evidence of clinically active interstitial lung disease
PRIOR CONCURRENT THERAPY:
Patients may not have received more than one previous systemic treatment regimen
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 |
Study Chair: | David J. Adelstein, MD | The Cleveland Clinic |
Study ID Numbers: | CDR0000449669, CASE-CCF-5538, ZENECA-1839IL/0234 |
Study First Received: | December 20, 2005 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00268346 |
Health Authority: | Unspecified |
adenocarcinoma of the esophagus recurrent esophageal cancer squamous cell carcinoma of the esophagus stage IV esophageal cancer |
Digestive System Neoplasms Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Squamous cell carcinoma Recurrence Carcinoma Epidermoid carcinoma Digestive System Diseases |
Head and Neck Neoplasms Carcinoma, squamous cell Neoplasm Metastasis Gastrointestinal Neoplasms Esophageal Diseases Carcinoma, Squamous Cell Adenocarcinoma Gefitinib Esophageal neoplasm |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |