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

NCT00524121 | Completed Phase 2 Results DMC

• 2 other identifiers: CDR0000563268RPCI-I-62705
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

adenocarcinoma of the esophagus; squamous cell carcinoma of the esophagus; stage I esophageal cancer; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  5 years

Secondary Outcomes (7)

• Complete Response

  4-8 weeks after completion of radiation.

• Progresssion-Free Survival

  Every 3 months, up to 5 years

• Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale

  Baseline and Week 3

• Correlation of Smoking Status With Overall Survival

  5 years

• Response by Epidermal Growth Factor Receptor (EGFR) Expression

  Radiologic evaluation every 3 months, up to 5 years

Study Arms (1)

Oral Erlotinib

EXPERIMENTAL

Patients receive oral erlotinib hydrochloride once daily for 1 year

Drug: erlotinib hydrochloride; Other: immunohistochemistry staining method; Radiation: radiation therapy

Interventions

erlotinib hydrochloride DRUG

Oral

Oral Erlotinib

immunohistochemistry staining method OTHER

Correlative Study

Oral Erlotinib

radiation therapy RADIATION

Radiation Treatment

Oral Erlotinib

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

DISEASE CHARACTERISTICS: * Biopsy-proven primary squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction * GE junction tumors with 50% or more tumor located in the esophagus determined by radiologic or endoscopic evaluation * Stage I-IVA disease determined by CT scan or MRI of the chest and abdomen * Stage IVB disease allowed if metastases to distant regional lymph nodes (celiac or cervical) only and no other sites * Not a surgical candidate and ineligible for chemotherapy due to any of the following: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Erlotinib Hydrochloride; Immunohistochemistry; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Therapeutics

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Renuka Iyer, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 3, 2007
• Study Start: March 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: October 1, 2011
• Last Updated: April 14, 2016
• Results First Posted: March 5, 2015

Record last verified: 2016-03

Locations

US (1)