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.
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
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- 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
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.
- Conditions
- Esophageal Cancer
- 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.
erlotinib hydrochlorideDrug
Oral
immunohistochemistry staining methodOther
Correlative Study
radiation therapyRadiation
Radiation Treatment
| Study group | Role | What they receive |
|---|---|---|
| Oral Erlotinib | Experimental | Patients 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.
Overall Survival
Measured: 5 years
Secondary outcomes (7)
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.
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
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
Correlation of Smoking Status With Overall Survival
Measured: 5 years
Response by Epidermal Growth Factor Receptor (EGFR) Expression
Measured: Radiologic evaluation every 3 months, up to 5 years
Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression
Measured: Radiologic evaluation every 3 months, up to 5 years
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.
- First posted3 Sep 2007 (estimated)
- Study startMar 2006
- Primary completionMay 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renuka Iyer, MD, Principal investigator, Roswell Park Cancer Institute
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Erlotinib (Tarceva®) and Radiotherapy for Elderly Patients With Esophageal Carcinoma
- ClinicalTrials.gov ID
- NCT00524121
- Acronym / sponsor ID
- CDR0000563268
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- May 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Posted 5 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Erlotinib | Experimental | Drug: erlotinib hydrochloride, Other: immunohistochemistry staining method, Radiation: radiation therapyPatients receive oral erlotinib hydrochloride once daily for 1 year |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erlotinib hydrochlorideOral | Drug | Oral Erlotinib |
| immunohistochemistry staining methodCorrelative Study | Other | Oral Erlotinib |
| radiation therapyRadiation Treatment | Radiation | Oral Erlotinib |
Primary outcome
Overall Survival
Time frame: 5 years
7 secondary outcomes
Complete Response
Time frame: 4-8 weeks after completion of radiation.
Progresssion-Free Survival
Time frame: Every 3 months, up to 5 years
Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale
Time frame: Baseline and Week 3
Correlation of Smoking Status With Overall Survival
Time frame: 5 years
Response by Epidermal Growth Factor Receptor (EGFR) Expression
Time frame: Radiologic evaluation every 3 months, up to 5 years
Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression
Time frame: Radiologic evaluation every 3 months, up to 5 years
Response by EGFR Mutation Status
Time frame: Radiologic evaluation every 3 months, up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renuka Iyer, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
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.