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Esophageal CancerPhase 2NCT00524121

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

A Phase 2 study testing erlotinib hydrochloride, immunohistochemistry staining method and radiation therapy in people with Esophageal Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 120 years
Conditions the study is for
Esophageal Cancer
What is being tested?
erlotinib hydrochloride, immunohistochemistry staining method and radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
Mar 2006to Oct 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 120 years
  • All sexes
  • No healthy volunteers
  • Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
erlotinib hydrochloride, immunohistochemistry staining method, radiation therapy
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
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00524121
Study groupRoleWhat they receive
Oral ErlotinibExperimentalPatients receive oral erlotinib hydrochloride once daily for 1 year
Receives: Drug: erlotinib hydrochloride; Other: immunohistochemistry staining method; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: 5 years

Secondary outcomes (7)
  1. 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.

    Measured: 4-8 weeks after completion of radiation.

  2. 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.

    Measured: Every 3 months, up to 5 years

  3. 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

    Measured: Baseline and Week 3

  4. Correlation of Smoking Status With Overall Survival

    Measured: 5 years

  5. Response by Epidermal Growth Factor Receptor (EGFR) Expression

    Measured: Radiologic evaluation every 3 months, up to 5 years

  6. Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression

    Measured: Radiologic evaluation every 3 months, up to 5 years

  7. Response by EGFR Mutation Status

    Measured: Radiologic evaluation every 3 months, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2007 (estimated)
  2. Study startMar 2006
  3. Primary completionMay 2010
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00524121
Sponsor's protocol ID
CDR0000563268
Other IDs
RPCI-I-62705
Status last verified
Mar 2016
First submitted
31 Aug 2007
Last updated
14 Apr 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib hydrochloride, immunohistochemistry staining method and radiation therapy in people with Esophageal Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.

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