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Status:

COMPLETED

Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Esophageal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 ...

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 gefiti...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2009

    Estimated Enrollment :

    70 Patients enrolled

    Trial Details

    Trial ID

    NCT00100945

    Start Date

    July 1 2005

    End Date

    October 1 2009

    Last Update

    December 13 2016

    Active Locations (119)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 30 (119 locations)

    1

    Mobile Infirmary Medical Center

    Mobile, Alabama, United States, 36652-2144

    2

    Mayo Clinic - Jacksonville

    Jacksonville, Florida, United States, 32224

    3

    Rush-Copley Cancer Care Center

    Aurora, Illinois, United States, 60507

    4

    St. Joseph Medical Center

    Bloomington, Illinois, United States, 61701