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
  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 locally advanced esophageal cancer.


Condition Intervention Phase
Esophageal Cancer
Drug: gefitinib
Procedure: adjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 1-year overall survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 72
Study Start Date: July 2005
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100945

  Show 119 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Aminah Jatoi, MD Mayo Clinic
Investigator: George P. Kim, MD Mayo Clinic
Investigator: Jeff Sloan, PhD Mayo Clinic
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00100945     History of Changes
Other Study ID Numbers: CDR0000407534, NCCTG-N0342
Study First Received: January 7, 2005
Last Updated: October 13, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014