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Gefitinib in Treating Patients With Recurrent or Metastatic Esophageal or Gastroesophageal Junction Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00268346
  Purpose

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
Esophageal Cancer
Drug: gefitinib
Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders
Drug Information available for: ZD1839
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response to treatment at 8 weeks after initiation of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as measured by CTC version 2.0 every 8 weeks [ Designated as safety issue: Yes ]
  • Quality of life as measured by FACT-E version 4 every 8 weeks [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: October 2005
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Explore the activity of single agent gefitinib, in terms of response rate, in a patient population with recurrent or metastatic esophageal or gastroesophageal junction cancer.

Secondary

  • Assess the toxicity of this drug in these patients.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pathologically confirmed squamous cell carcinoma, adenocarcinoma, or large-cell undifferentiated carcinoma of the esophagus or gastroesophageal junction

    • Patients must have disease that is either metastatic (i.e., M1b by the definitions of the American Joint Committee on Cancer 1997 staging system) or recurrent after definitive therapy, and must be considered incurable by conventional treatments
    • Patients with small cell, or mixed small cell/non-small-cell histology are ineligible
    • Patients with lymphoma or sarcoma are also ineligible
  • Disease must be measurable in at least one dimension by physical exam, x-ray, CT scan or MRI, ultrasound, or endoscopy

    • Measurable disease can be a previously irradiated lesion if disease growth has been documented in the lesion since completion of radiation therapy
    • An elevation in carcinoembryonic antigen (CEA) is not sufficient to use by itself in response assessment

PATIENT CHARACTERISTICS:

  • ECOG Performance Status 0-1
  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 2.0 mg/dL
  • Alkaline phosphatase and AST < twice normal
  • Bilirubin < twice normal
  • Calcium normal
  • No known severe hypersensitivity to study drug or any of its excipients
  • No clinical evidence of any other uncontrolled malignancy except adequately treated basal or squamous cell skin cancer or in situ cervical cancer
  • Pregnant or nursing women are ineligible
  • Fertile patients must use effective contraception
  • No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • No evidence of clinically active interstitial lung disease

    • Patients with chronic stable radiographic changes who are asymptomatic need not be excluded

PRIOR CONCURRENT THERAPY:

  • Patients may not have received more than one previous systemic treatment regimen

    • Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease
    • Previously untreated patients are also eligible
  • No previous treatment with study drug or any other epidermal growth factor receptor (EGFR) antagonists
  • More than 30 days since prior treatment with a non-approved or investigational drug
  • At least 4 weeks must have elapsed since any surgery, radiation therapy, or chemotherapy administration
  • Recovered from previous oncologic or other major surgery
  • No concurrent barbiturates (e.g., phenytoin), carbamazepine, rifampicin, phenobarbital or Hypericum perforatum (St. John's wort)
  • No concurrent surgery, radiation therapy, hormonal therapy, or other chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268346

Locations
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        
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: David J. Adelstein, MD The Cleveland Clinic
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the esophagus
recurrent esophageal cancer
squamous cell carcinoma of the esophagus
stage IV esophageal cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009