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

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ZD1839
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, recurrent esophageal cancer, squamous cell carcinoma of the esophagus, stage IV esophageal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ZD1839

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 20, 2005
Last Updated
December 4, 2015
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00268346
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
adenocarcinoma of the esophagus, recurrent esophageal cancer, squamous cell carcinoma of the esophagus, stage IV esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZD1839
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ZD1839
Other Intervention Name(s)
IRESSA®, Gefitinib
Intervention Description
ZD1839 treatment will be taken once a day PO, every day about the same time
Primary Outcome Measure Information:
Title
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.
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.
Time Frame
at 8 weeks after initiation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Adelstein, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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

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