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

Adenocarcinoma of the Gastroesophageal Junction Clinical Trial

Official title:

Phase II Study Of OSI-774 In Advanced Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045526
• Other study ID #: NCI-2012-01418
• Secondary ID: 02-035NSC-718781
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2002
• Last updated: June 3, 2013
• Start date: June 2002

Study information

• Verified date: June 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Esophagus
• Adenocarcinoma of the Gastroesophageal Junction
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Recurrent Esophageal Cancer
• Squamous Cell Carcinoma of the Esophagus
• Stage III Esophageal Cancer
• Stage IV Esophageal Cancer

Intervention

Drug:
• erlotinib hydrochloride
Given PO

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major response rate (complete and partial response)		Up to 5 years	No
Secondary	Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)		Up to 5 years	Yes
Secondary	Degree of dysphagia relief		Up to 5 years	No
Secondary	Time to progression	Estimated using the Kaplan-Meier method and confidence intervals will be formed for median time to progression.	Up to 5 years	No
Secondary	Overall survival	Estimated using the Kaplan-Meier method and confidence intervals will be formed for median survival time.	Up to 5 years	No