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

Phase II Study Of OSI-774 In Advanced Esophageal Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00045526
Enrollment
48
Registered
2003-01-27
Start date
2002-06-30
Completion date
Unknown
Last updated
2013-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGerlotinib hydrochloride

Given PO

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Major response rate (complete and partial response)Up to 5 years

Secondary

MeasureTime frameDescription
Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)Up to 5 years
Degree of dysphagia reliefUp to 5 years
Time to progressionUp to 5 yearsEstimated using the Kaplan-Meier method and confidence intervals will be formed for median time to progression.
Overall survivalUp to 5 yearsEstimated using the Kaplan-Meier method and confidence intervals will be formed for median survival time.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026