Erlotinib in Treating Patients With Barrett Esophagus
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kansas City Veteran Affairs Medical Center
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00566800
First received: December 1, 2007
Last updated: January 27, 2010
Last verified: January 2008
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Purpose
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Erlotinib may keep esophageal cancer from forming in patients with Barrett esophagus by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with Barrett esophagus.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Precancerous Condition |
Drug: erlotinib hydrochloride Other: laboratory biomarker analysis Procedure: biopsy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy [ Designated as safety issue: No ]
- Validation of histologic scoring of Barrett dysplasia [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 25 |
| Study Start Date: | July 2007 |
OBJECTIVES:
Primary
- To determine if erlotinib hydrochloride can be used as a chemopreventive agent that can cause histologic regression of Barrett esophagus in patients at high risk of developing esophageal cancer associated with high-grade dysplasia.
Secondary
- To assess whether erlotinib hydrochloride can cause molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy in Barrett esophagus with high-grade dysplasia.
- To establish surrogate markers of chemoprevention in Barrett esophagus with high-grade dysplasia.
- To validate the histologic scoring of Barrett dysplasia developed by our group.
- To evaluate toxicities associated with the use of erlotinib hydrochloride in patients with Barrett esophagus associated with high-grade dysplasia.
OUTLINE: Patients receive oral erlotinib hydrochloride once daily for 3 months. Patients showing no evidence of progression to cancer by esophagogastroduodenoscopy (EGD) with biopsy receive an additional 3 months of treatment. All patients then undergo repeat EGD, biopsy, and determination of molecular markers (i.e., EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy).
After completion of study treatment, patients are followed for 30 days.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of Barrett esophagus with high-grade dysplasia
- Refused surgery or other localized therapy for high-grade dysplasia
- No invasive esophageal carcinoma
PATIENT CHARACTERISTICS:
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Bilirubin normal
- AST and ALT < 3 times upper limit of normal (ULN)
- Alkaline phosphatase < 3 times ULN
- No uncontrolled medical condition
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 1 week after completion of study treatment
- Able to swallow tablets or dissolved tablets
- No known hypersensitivity to erlotinib hydrochloride
- No symptoms suggestive of malignancy (e.g., weight loss or vomiting)
- No history of other malignancies
- No uncontrolled medical or psychiatric condition that would preclude treatment under this clinical trial
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior exposure to erlotinib hydrochloride
- No concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal therapy
- No concurrent investigational agents
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566800
Locations
| United States, Missouri | |
| Veterans Affairs Medical Center - Kansas City | Recruiting |
| Kansas City, Missouri, United States, 64128 | |
| Contact: Joaquina C. Baranda, MD 816-861-4700 ext 6708 joaquina.baranda2@med.va.gov | |
Sponsors and Collaborators
Kansas City Veteran Affairs Medical Center
Investigators
| Principal Investigator: | Joaquina C. Baranda, MD | Kansas City Veteran Affairs Medical Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00566800 History of Changes |
| Other Study ID Numbers: | CDR0000576425, VAMCK-JB0027, GENENTECH-OSI3717s |
| Study First Received: | December 1, 2007 |
| Last Updated: | January 27, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
esophageal cancer Barrett esophagus |
Additional relevant MeSH terms:
|
Barrett Esophagus Esophageal Diseases Esophageal Neoplasms Precancerous Conditions Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Neoplasms Head and Neck Neoplasms Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013