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Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT00100945
Recruitment Status : Completed
First Posted : January 10, 2005
Last Update Posted : December 13, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

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 locally advanced esophageal cancer.


Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: gefitinib Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • Determine the 1-year overall survival rate in patients with previously treated locally advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with gefitinib as maintenance therapy.

Secondary

  • Determine disease-free survival and time to disease recurrence in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Determine the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity.

Quality of life is assessed at baseline, 4 weeks, every 12 weeks during study treatment, and then at the end of study treatment.

Patients are followed every 3 months for up to 5 years.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Maintenance ZD1839 (IRESSA) In Patients With Locally Advanced Esophageal Cancer After Treatment Given With Curative Intent
Study Start Date : July 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: gefitinib

Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity.

Quality of life is assessed at baseline, 4 weeks, every 12 weeks during study treatment, and then at the end of study treatment.

Patients are followed every 3 months for up to 5 years.

Drug: gefitinib



Primary Outcome Measures :
  1. 1-year overall survival rate [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Survival time [ Time Frame: Up to 5 years ]
  2. Disease-free survival [ Time Frame: Up to 5 years ]
  3. Time to disease recurrence [ Time Frame: Up to 5 years ]
  4. Time to treatment failure [ Time Frame: Up to 5 years ]
  5. Quality of life [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction

    • Locally advanced disease

      • T3 or T4 tumor with no lymph node involvement OR any T stage with local lymph node involvement

        • Celiac node involvement allowed
        • No supraclavicular lymph node involvement
  • Received potentially curative chemotherapy, radiotherapy, and/or surgery within the past 1-3 months

    • Patients who received adjuvant chemotherapy or chemoradiotherapy after surgery are eligible provided last treatment was administered within the past 3 months
  • No evidence of residual tumor or metastatic disease after undergoing potentially curative therapy

    • No positive margins at the time of prior surgery
    • No measurable or evaluable disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 2.0 mg/dL

Renal

  • Creatinine ≤ 2 times upper limit of normal

Cardiovascular

  • No New York Heart Association class III or IV heart disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to swallow study drug
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics

Other

  • No prior gefitinib
  • No concurrent CYP3A4 inducing agents, including any of the following:

    • Carbamazepine
    • Oxcarbazepine
    • Modafinil
    • Ethosuximide
    • Griseofulvin
    • Nafcillin
    • Phenobarbital
    • Phenylbutazone
    • Phenytoin
    • Primidone
    • Rifampin
    • Hypericum perforatum (St. John's wort)
    • Sulfinpyrazone
  • No concurrent antacids 4 hours before or after study drug administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100945


  Show 119 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Aminah Jatoi, MD Mayo Clinic

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00100945     History of Changes
Other Study ID Numbers: NCCTG-N0342
NCI-2012-02644 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000407534 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 10, 2005    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
adenocarcinoma of the esophagus
stage II esophageal cancer

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
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action