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Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer

Primary Purpose

Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Recurrent Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
erlotinib hydrochloride
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Esophagus

Eligibility Criteria

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

Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma, squamous cell or small cell carcinoma, or carcinoma not otherwise specified of the esophagus or gastroesophageal junction Metastatic or surgically unresectable disease Measurable disease outside of primary tumor At least 20 mm by conventional techniques OR at least 10 mm by spiral computed tomography (CT) scan No bone metastases, abnormal radionuclide bone scans, or pleural effusions as only site of measurable disease No known brain metastases or carcinomatous meningitis Must consent to having tumor tissue tested for epidermal growth factor receptor status Performance status-Karnofsky 70-100% Life expectancy of greater than 3 months Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 2 times upper limit of normal (ULN) Aspartate aminotransferase (AST) no greater than 2 times ULN Creatinine no greater than 1.5 mg/dL Calcium no greater than 12 mg/dL No symptomatic hypercalcemia No symptomatic congestive heart failure No unstable angina pectoris No ventricular arrhythmia No other malignancy within the past 3 years except adequately treated carcinoma in situ of the cervix, superficial transitional cell carcinoma of the bladder, or basal cell or squamous cell skin cancer No other uncontrolled concurrent illness No ongoing or active infection No psychiatric illness or social situation that would preclude study participation No other concurrent disease that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior cetuximab No more than 1 prior chemotherapy regimen for advanced or metastatic disease One prior chemotherapy in the adjuvant setting (in combination with prior surgery or radiotherapy) allowed provided it was administered prior to treatment for advanced or metastatic disease At least 3 weeks since prior chemotherapy No concurrent investigational or commercial chemotherapy At least 3 weeks since prior radiotherapy No prior erlotinib-related compounds or compounds of similar biologic or chemical components No prior EGFR-targeting compounds (e.g., gefitinib) No other concurrent investigational agents No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (erlotinib hydrochloride)

Arm Description

Patients receive erlotinib hydrochloride PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Major response rate (complete and partial response)

Secondary Outcome Measures

Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
Degree of dysphagia relief
Time to progression
Estimated using the Kaplan-Meier method and confidence intervals will be formed for median time to progression.
Overall survival
Estimated using the Kaplan-Meier method and confidence intervals will be formed for median survival time.

Full Information

First Posted
September 6, 2002
Last Updated
June 3, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00045526
Brief Title
Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Official Title
Phase II Study Of OSI-774 In Advanced Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase II trial is studying erlotinib hydrochloride to see how well it works in treating patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with advanced carcinoma of the esophagus or gastroesophageal junction treated with erlotinib (erlotinib hydrochloride). II. Determine the overall survival of patients treated with this drug. III. Determine the degree of dysphagia relief in patients treated with this drug. IV. Determine the toxicity and tolerability of this drug in these patients. V. Correlate epidermal growth factor receptor (EGFR) expression with response to treatment in these patients. OUTLINE: Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Recurrent Esophageal Cancer, Squamous Cell Carcinoma of the Esophagus, Stage III Esophageal Cancer, 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
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (erlotinib hydrochloride)
Arm Type
Experimental
Arm Description
Patients receive erlotinib hydrochloride PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Other Intervention Name(s)
CP-358,774, erlotinib, OSI-774
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Major response rate (complete and partial response)
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
Time Frame
Up to 5 years
Title
Degree of dysphagia relief
Time Frame
Up to 5 years
Title
Time to progression
Description
Estimated using the Kaplan-Meier method and confidence intervals will be formed for median time to progression.
Time Frame
Up to 5 years
Title
Overall survival
Description
Estimated using the Kaplan-Meier method and confidence intervals will be formed for median survival time.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma, squamous cell or small cell carcinoma, or carcinoma not otherwise specified of the esophagus or gastroesophageal junction Metastatic or surgically unresectable disease Measurable disease outside of primary tumor At least 20 mm by conventional techniques OR at least 10 mm by spiral computed tomography (CT) scan No bone metastases, abnormal radionuclide bone scans, or pleural effusions as only site of measurable disease No known brain metastases or carcinomatous meningitis Must consent to having tumor tissue tested for epidermal growth factor receptor status Performance status-Karnofsky 70-100% Life expectancy of greater than 3 months Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 2 times upper limit of normal (ULN) Aspartate aminotransferase (AST) no greater than 2 times ULN Creatinine no greater than 1.5 mg/dL Calcium no greater than 12 mg/dL No symptomatic hypercalcemia No symptomatic congestive heart failure No unstable angina pectoris No ventricular arrhythmia No other malignancy within the past 3 years except adequately treated carcinoma in situ of the cervix, superficial transitional cell carcinoma of the bladder, or basal cell or squamous cell skin cancer No other uncontrolled concurrent illness No ongoing or active infection No psychiatric illness or social situation that would preclude study participation No other concurrent disease that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior cetuximab No more than 1 prior chemotherapy regimen for advanced or metastatic disease One prior chemotherapy in the adjuvant setting (in combination with prior surgery or radiotherapy) allowed provided it was administered prior to treatment for advanced or metastatic disease At least 3 weeks since prior chemotherapy No concurrent investigational or commercial chemotherapy At least 3 weeks since prior radiotherapy No prior erlotinib-related compounds or compounds of similar biologic or chemical components No prior EGFR-targeting compounds (e.g., gefitinib) No other concurrent investigational agents No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ilson
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

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Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer

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