Erlotinib and Radiation Therapy in Treating Older Patients With Stage I, Stage II, Stage III, or Stage IV Esophageal Cancer

NCT ID: NCT00524121

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2011-10-31

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with radiation therapy works in treating older patients with stage I, stage II, stage III, or stage IV esophageal cancer.

Detailed Description

OBJECTIVES:

Primary

• Assess the overall survival of older patients with stage I-IV squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction treated with erlotinib hydrochloride in combination with radiotherapy.

Secondary

• Assess the proportion of patients achieving mucosal complete response after treatment with this regimen.
• Determine the progression-free survival of patients treated with this regimen.
• Assess the effect of this regimen on dysphagia control, performance status, and overall quality of life of these patients.
• Investigate the correlation between smoking status and overall survival of these patients.
• To correlate the Epidermal growth factor receptor (EGFR) and phosphor Epidermal growth factor receptor (pEGFR) expression by IHC and EGFR mutation status with clinical outcomes.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo external beam radiotherapy 5 days a week in weeks 1-4 or 5 days a week for the first 5.5 weeks.

Tumor tissue samples are analyzed by IHC for the expression of E-cadherin, P-cadherin, vimentin, cytokeratin, phospho-S6, and Ki67.

After completion of study treatment, patients are followed at 30 days and annually thereafter.

Conditions

Esophageal Cancer

Study Design

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

Study Groups

Oral Erlotinib

Patients receive oral erlotinib hydrochloride once daily for 1 year

Group Type: EXPERIMENTAL

radiation therapy

Intervention Type: RADIATION

Radiation Treatment

erlotinib hydrochloride

Intervention Type: DRUG

Oral

immunohistochemistry staining method

Intervention Type: OTHER

Correlative Study

Interventions

radiation therapy

Radiation Treatment

Intervention Type: RADIATION

erlotinib hydrochloride

Oral

Intervention Type: DRUG

immunohistochemistry staining method

Correlative Study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Neuropathy
• Cardiac disease
• Performance status 2
• General overall condition felt by the investigator to be a contraindication to platinum-based therapy
• Bronchoscopy with biopsy and cytology required if primary esophageal cancer is < 26 cm from incisors
• No evidence of clinically active interstitial lung disease (patients who are asymptomatic with chronic, stable, radiographic lung changes allowed)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Life expectancy > 4 months
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count > 100,000/mm³
• Bilirubin ≤ 1.3 mg/dL
• ALT and AST ≤ 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• No prior malignancies except basal cell or squamous cell skin cancer, in situ cervical cancer, or superficial transitional cell bladder cancer, unless diagnosed and/or treated > 2 years prior to current study and are without evidence of recurrence
• No history of allergy to erlotinib or any of its excipients
• No serious, uncontrolled, concurrent infection
• No clinically serious, uncontrolled medical conditions that the investigator feels might compromise study participation
• No lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
• No unwillingness to participate or inability to comply with the protocol for the duration of the study

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy for this tumor
• No prior resection or attempted resection of esophageal cancer
• No prior anti-epidermal growth factor receptor therapy (unless given in an adjuvant setting and completed at least 12 months earlier)
• No participation in any investigational drug study within the past 4 weeks
• No HIV-positive patients receiving antiretroviral therapy
• No concurrent CYP3A4/5 inducers or inhibitors

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renuka Iyer, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-I-62705

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000563268

Identifier Type: -

Identifier Source: org_study_id