Gefitinib in Treating Patients With Recurrent or Metastatic Esophageal or Gastroesophageal Junction Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268346
• Other study ID #: CCF5538
• Secondary ID: P30CA043703CCF-5
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2005
• Last updated: December 4, 2015
• Start date: October 2005
• Est. completion date: August 2011

Study information

• Verified date: December 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• ZD1839
ZD1839 treatment will be taken once a day PO, every day about the same time

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	at 8 weeks after initiation of treatment	No