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

Primary Purpose

Esophageal Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

erlotinib hydrochloride

immunohistochemistry staining method

radiation therapy

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring 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

Eligibility Criteria

65 Years - 120 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Erlotinib

Arm Description

Patients receive oral erlotinib hydrochloride once daily for 1 year

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Complete Response

Response assessment by CT scans and upper endoscopy performed between 4-8 weeks after completion of radiation. Complete Response (CR) is defined as absence of viable tumor in endoscopic evaluation post chemoradiation, with four-quadrant biopsies taken at 1 cm intervals throughout length of original tumor.

Progresssion-Free Survival

Progression is defined as at least a 20% increase in the sum of long distance of target lesions taking as reference the smallest sum long distance recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

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

Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health-related quality of life instrument validated in esophageal cancer patients. All of the scales and single-item measures range in score from 0 to 4. The ranges of average quality of life scores was from 0 to 4 and was adjusted as lower scores indicate better outcomes

Correlation of Smoking Status With Overall Survival

Response by Epidermal Growth Factor Receptor (EGFR) Expression

Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression

Response by EGFR Mutation Status

Full Information

NCT ID

NCT00524121

First Posted

August 31, 2007

Last Updated

March 14, 2016

Sponsor

Roswell Park Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT00524121

Brief Title

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

Official Title

Phase II Study of Erlotinib (Tarceva®) and Radiotherapy for Elderly Patients With Esophageal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Erlotinib

Arm Type

Experimental

Arm Description

Patients receive oral erlotinib hydrochloride once daily for 1 year

Intervention Type

Drug

Intervention Name(s)

erlotinib hydrochloride

Intervention Description

Oral

Intervention Type

Other

Intervention Name(s)

immunohistochemistry staining method

Intervention Description

Correlative Study

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Intervention Description

Radiation Treatment

Primary Outcome Measure Information:

Title

Overall Survival

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Complete Response

Description

Time Frame

4-8 weeks after completion of radiation.

Title

Progresssion-Free Survival

Description

Time Frame

Every 3 months, up to 5 years

Title

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

Description

Time Frame

Baseline and Week 3

Title

Correlation of Smoking Status With Overall Survival

Time Frame

5 years

Title

Response by Epidermal Growth Factor Receptor (EGFR) Expression

Time Frame

Radiologic evaluation every 3 months, up to 5 years

Title

Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression

Time Frame

Radiologic evaluation every 3 months, up to 5 years

Title

Response by EGFR Mutation Status

Time Frame

Radiologic evaluation every 3 months, up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renuka Iyer, MD

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263-0001

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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