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

NCT ID: NCT00045526

Last Updated: 2013-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (erlotinib hydrochloride)

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

Group Type: EXPERIMENTAL

erlotinib hydrochloride

Intervention Type: DRUG

Given PO

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

erlotinib hydrochloride

Given PO

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

CP-358,774; erlotinib; OSI-774

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Ilson

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

02-035

Identifier Type: -

Identifier Source: secondary_id

NSC-718781

Identifier Type: -

Identifier Source: secondary_id

NCI-5445

Identifier Type: -

Identifier Source: secondary_id

CDR0000256601

Identifier Type: -

Identifier Source: secondary_id

MSKCC-02035

Identifier Type: -

Identifier Source: secondary_id

N01CM62206

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-01418

Identifier Type: -

Identifier Source: org_study_id