Esophageal CancerPhase 2NCT00258297
Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery
A Phase 2 study testing gefitinib, conventional surgery and enzyme inhibitor therapy in people with Esophageal Cancer, run by University of Rochester at 1 site in United States.
Trial summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can be removed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- gefitinib, conventional surgery and enzyme inhibitor therapy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Nov 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell or adenocarcinoma of the thoracic esophagus
- Resectable, localized disease with or without metastases in local lymph nodes (T1, T2, or T3; any N; M0)
- Stage I-III disease
- No known distant metastases
- No cervical-esophageal tumors (upper border < 18 cm from the incisor teeth)
- No supraclavicular metastases
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Adequate bone marrow function
Hepatic
- Adequate hepatic function
- No unstable or uncompensated hepatic disease
Renal
- Creatinine ≤ grade 2 by Common Toxicity Criteria
- Adequate renal function
- No unstable or uncompensated renal disease
Cardiovascular
- No unstable or uncompensated cardiac disease
Pulmonary
- No clinically active interstitial lung disease unless it is asymptomatic with chronic stable radiographic changes
- No unstable or uncompensated respiratory disease
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No known hypersensitivity to gefitinib or any of the excipients
- No other malignancy within the past 2 years except basal cell carcinoma or carcinoma in situ of the cervix
- No evidence of severe or uncontrolled systemic disease
- No other significant clinical disorder or laboratory finding that would preclude study participation
PRIOR CONCURRENT THERAPY:
Endocrine therapy
- Concurrent stable-dose steroids allowed
Surgery
- Recovered from any prior oncologic or other major surgery
Other
- More than 30 days since prior nonapproved or investigational drug
- No prior therapy for this or any other malignancy
- No concurrent phenytoin, carbamazepine, barbiturates, rifampin, or Hypericum perforatum (St. John's wort)
Trial locations and contacts
1 site in 1 country.
United States1 site
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage I, stage II, or stage III esophageal cancer that can be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety and tolerability of neoadjuvant gefitinib in patients with resectable stage I-III esophageal cancer.
Secondary
- Determine the epidermal growth factor-receptor expression in tissue samples obtained at diagnosis and surgery from patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral gefitinib once daily beginning between days -21 and -14 and continuing until day -1. Patients undergo tumor resection on day 0.
After completion of study treatment, patients are followed periodically for 6 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Conditions
- Esophageal Cancer
- Being tested
- gefitinib, conventional surgery, enzyme inhibitor therapy, neoadjuvant therapy, protein tyrosine kinase inhibitor therapy
- Keywords
- stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus
- 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.
gefitinibDrug
conventional surgeryProcedure or surgery
enzyme inhibitor therapyProcedure or surgery
neoadjuvant therapyProcedure or surgery
protein tyrosine kinase inhibitor therapyProcedure or surgery
surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startApr 2004
- Primary completionNov 2006
- Study completionNov 2006
Why it stopped: Withdrawn for lack of funding and accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kishan J. Pandya, MD, Study chair, James P. Wilmot Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258297
- Sponsor's protocol ID
- CDR0000447159
- Other IDs
- URCC-U2203, ZENECA-1839US/0282
- Status last verified
- Oct 2013
- First submitted
- 22 Nov 2005
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00258297
- Acronym / sponsor ID
- CDR0000447159
- Conditions
- Esophageal Cancer
- Keywords
- stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawn for lack of funding and accrual
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 24 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage I, stage II, or stage III esophageal cancer that can be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- Determine the safety and tolerability of neoadjuvant gefitinib in patients with resectable stage I-III esophageal cancer.
Secondary
- Determine the epidermal growth factor-receptor expression in tissue samples obtained at diagnosis and surgery from patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral gefitinib once daily beginning between days -21 and -14 and continuing until day -1. Patients undergo tumor resection on day 0.
After completion of study treatment, patients are followed periodically for 6 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, 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 |
|---|---|---|
| gefitinib | Drug | – |
| conventional surgery | Procedure or surgery | – |
| enzyme inhibitor therapy | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
| protein tyrosine kinase inhibitor therapy | Procedure or surgery | – |
| surgery | Procedure or surgery | – |
Primary outcome
Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib
Results and safety
The study was stopped early (reason given: Withdrawn for lack of funding and accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
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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.
Kishan J. Pandya, MD study chair
James P. Wilmot Cancer Center
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 gefitinib, conventional surgery and enzyme inhibitor therapy in people with Esophageal Cancer, run by University of Rochester 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: stopped early, as of the sponsor's last update on 16 Oct 2013. 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?
The study was stopped early (reason given: Withdrawn for lack of funding and accrual). Results are not available in the source record.
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?
Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib. 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 16 Oct 2013.