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A Phase II Trial of ZD1839 (IRESSA®) for Patients With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

A Phase II Trial of ZD1839 (IRESSA®) for Patients With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction



- 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.


- 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.

Inclusion Criteria


- 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

- 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


- 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


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Number of Patients With Complete or Partial Response Rate of Single Agent ZD1839 in a Patient Population With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction, Using the RECIST 1.0 Criteria.

Outcome Description:

The overall response is the number of patients with the best response recorded in measurable disease (target lesions) from start to disease progression.Complete response is the number of patients with the disappearance of all target lesions. Partial response is the number of patients with larger than or equal to 30% decrease in sum of the longest diameters from baseline. Progressive disease is larger than or equal to 20% increase in sum of the longest diameters over the smallest sum observed or appearance of new lesions. Stable disease is neither PR nor PD criteria met.

Outcome Time Frame:

at 8 weeks after initiation of treatment

Safety Issue:


Principal Investigator

David J. Adelstein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

August 2011

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • recurrent esophageal cancer
  • squamous cell carcinoma of the esophagus
  • stage IV esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195