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

June 3, 2013 updated by: National Cancer Institute (NCI)

Phase II Study Of OSI-774 In Advanced Esophageal Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (erlotinib hydrochloride)
Patients receive erlotinib hydrochloride PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
Correlative studies
Drug: erlotinib hydrochloride
Given PO
Other Names:
  • OSI-774
  • erlotinib
  • CP-358,774

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major response rate (complete and partial response)
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
Time Frame: Up to 5 years
Up to 5 years
Degree of dysphagia relief
Time Frame: Up to 5 years
Up to 5 years
Time to progression
Time Frame: Up to 5 years
Estimated using the Kaplan-Meier method and confidence intervals will be formed for median time to progression.
Up to 5 years
Overall survival
Time Frame: Up to 5 years
Estimated using the Kaplan-Meier method and confidence intervals will be formed for median survival time.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: David Ilson, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

September 6, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 4, 2013

Last Update Submitted That Met QC Criteria

June 3, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-01418
  • N01CM62206 (U.S. NIH Grant/Contract)
  • 02-035
  • NSC-718781
  • NCI-5445
  • CDR0000256601
  • MSKCC-02035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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