Symptoms and General Pathology

All Conditions

Neoplasms

Metaplasia

Precancerous Conditions

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients receive erlotinib hydrochloride PO QD for 90 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis

Pharmacological Study

Seema Khan

This phase I trial studies the side effects and best dose of erlotinib hydrochloride in preventing cancer in patients with precancerous lesions of the lung. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To determine the lowest dose of erlotinib (erlotinib hydrochloride) that will decrease the ratio of phosphorylated to total epidermal growth factor receptor (EGFR) (phosphorylated EGFR \[pEGFR\]/EGFR) by at least 20% in subjects with premalignant lesions of the lung. This will be accomplished by implementing a dose de-escalation trial of erlotinib (i.e., 75, 50, and 25 or 100 mg by mouth daily for a 3-month period), and determining the pEGFR/EGFR ratio in premalignant lesions of the lung epithelium by immunohistochemistry. Changes in the pEGFR/EGFR ratio will be assessed by comparing the pre-treatment (baseline) ratio to that of the post-treatment (3 month) ratio, measured in paraffin embedded biopsy specimens.

SECONDARY OBJECTIVES:

I. To determine the effect of erlotinib on the following biomarkers of potential biological relevance in paraffin embedded lung biopsies, p-v-akt murine thymoma viral oncogene homolog 1 (Akt), p-mitogen-activated protein kinase 1 (Erk), and marker of proliferation Ki-67 (Ki67).

II. To characterize the toxicity profile of erlotinib in this cohort of subjects.

III. To analyze and model erlotinib's pharmacokinetic/pharmacodynamic (PK/PD) profile. Serial blood samples will be drawn at the beginning and at the end of erlotinib treatment, and pharmacokinetic parameters will be determined. The status of EGFR genotype (and that of others genes linked to erlotinib PK/PD) clinical toxicity, and dose will be examined as possible other influential covariates by comparing them to experimentally measured PK profiles, and PD profiles (in particular, the pEGFR/EGFR ratio). The goal of these studies will be to determine the optimal biologic concentration (OBC) of Erlotinib that is associated with the lowest toxicity and highest effect, for a given subject's pharmacogenomic profile.

OUTLINE:

Patients receive erlotinib hydrochloride orally (PO) once daily (QD) for 90 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Erlotinib Hydrochloride in Preventing Cancer in Patients With Precancerous Lesions of the Lung

A Phase I Study of Erlotinib in Patients With Premalignant Lesions of the Lung

Analyzed using an analysis-of-variance (ANOVA) on the change from baseline expression level with a factor for dose (75, 50, 25 or 100). All tests will be two-sided and tested at level alpha=0.05. If the overall comparison is significant, pairwise comparisons will be done using straight Bonferroni adjustments.

Analyzed using an ANOVA on the change from baseline expression level with a factor for dose (75, 50, 25 or 100). All tests will be two-sided and tested at level alpha=0.05. If the overall comparison is significant, pairwise comparisons will be done using straight Bonferroni adjustments.

National Cancer Institute (NCI)

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Trametinib

1 mg taken by mouth once a day for 14 days

Trametinib treatment

A tiny camera on the end of a long, flexible tube will be used to examine the stomach and take biopsies.

Endoscopy

James Goldenring, MD

This is a study of the safety and effectiveness of Trametinib treatment in patients who have received successful endoscopic submucosal resection of a Stage I gastric cancer.

Objectives:

* To evaluate the efficacy of Trametinib in reversing metaplasia in participants with Stage 1 gastric cancer
* To evaluate the safety of Trametinibin in Stage I gastric cancer patients

Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor

Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor Treatment

The ability of Trametinib treatment to decrease the presence of metaplastic cell lineages in biopsies of the lining of the stomach, while also allowing the return of normal cell lineages (i.e. acid-secreting parietal cells). Cell lineages will be identified by immunostaining of tissue sections from biopsies.

Assessment of side effects induced during or after treatment with Trametinib.

Vanderbilt-Ingram Cancer Center

Principal Investigator

Anti-Infective Agents

Micronutrients

Vitamins

Acetic Acid

Retinol acetate

Vitamin A

Retinol palmitate

Anti-Bacterial Agents

Adjuvants, Immunologic

Immunologic Factors

Protective Agents

Retinol

Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy

Acetic acid chromoendoscopy

Kyung Ho Song, M.D., Master

The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high risk group of gastric cancer. Many methods was developed to survey it, including multiple gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The investigators have confirmed such whitish discoloration is induced in gastric IM, with accuracy \> 80% in a pilot study of the investigators. This prospective study will tell the accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.

Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia

Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %.

The findings of chromoendoscopy will be interpretated by two endoscoipists (read as positive or negative finding) independently.

We calculate the Kappa index of agreement for the acetic acid chromoendoscopy.

Number of Participants with Adverse Events. Assess kind of side effect and severity. Measured by interview with a physician, just after the procedure and 1weak later.

Konyang University Hospital

Assistant Professor

Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Erlotinib Hydrochloride in Preventing Cancer in Patients With Precancerous Lesions of the Lung	NCT01013831	Dysplasia Metaplasia Pulmonary Preca...	Erlotinib Hydro... Laboratory Biom... Pharmacological...	40 Years - 79 Years	National Cancer Institute (NCI)
Reversal of Preneoplastic Metaplasia in the Stomach With MEK Inhibitor	NCT04454476	Gastric Cancer Metaplasia Stage I Gastric... Initial-onset G...	Trametinib trea... Endoscopy	20 Years -	Vanderbilt-Ingram Cancer Center
Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia	NCT01499576	Stomach Neoplas... Metaplasia	Acetic acid chr...	35 Years - 70 Years	Konyang University Hospital

Spots Global Cancer Trial Database for metaplasia

Every month we try and update this database with for metaplasia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for metaplasia

Every month we try and update this database with for metaplasia cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for metaplasia cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.