Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00100945
First received: January 7, 2005
Last updated: October 13, 2009
Last verified: October 2009

January 7, 2005
October 13, 2009
July 2005
October 2009   (final data collection date for primary outcome measure)
1-year overall survival rate [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00100945 on ClinicalTrials.gov Archive Site
  • Survival time [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Time to disease recurrence [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer
A Phase II Study Of Maintenance ZD1839 (IRESSA) In Patients With Locally Advanced Esophageal Cancer After Treatment Given With Curative Intent

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.

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.

PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 9-24 months.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
  • Drug: gefitinib
  • Procedure: adjuvant therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
Not Provided
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00100945
CDR0000407534, NCCTG-N0342
Not Provided
Not Provided
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Aminah Jatoi, MD Mayo Clinic
Investigator: George P. Kim, MD Mayo Clinic
Investigator: Jeff Sloan, PhD Mayo Clinic
National Cancer Institute (NCI)
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP