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

Phase 2

Completed

• 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
• Interventions: Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis

• Registration Number: NCT00045526
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-09-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-03
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (erlotinib hydrochloride)	erlotinib hydrochloride	Patients receive erlotinib hydrochloride PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment (erlotinib hydrochloride)	laboratory biomarker analysis	Patients receive erlotinib hydrochloride PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Major response rate (complete and partial response)	Up to 5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States