Clinical trial NCT00268346: Gefitinib in Treating Patients With Recurrent or Metastatic Esophageal or Gastroesophageal Junction Cancer
Official title: A Phase II Trial of ZD1839 (IRESSA®) for Patients With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: adenocarcinoma of the esophagus
recurrent esophageal cancer
squamous cell carcinoma of the esophagus
stage IV esophageal cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-12-22
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 recurrent or metastatic esophageal or gastroesophageal junction cancer.

Detailed description: OBJECTIVES:

Primary

* 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.

Secondary

* 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* 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 ineligible
  * 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

PATIENT CHARACTERISTICS:

* 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

PRIOR CONCURRENT THERAPY:

* 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

Primary outcomes:
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.
timeFrame: at 8 weeks after initiation of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: David J. Adelstein, MD
role: STUDY_CHAIR
References: