Neoplasms

Nervous System Diseases

All Conditions

Rare Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Tumor, Adult

Brain Tumor, Childhood

gene expression analysis

genetic linkage analysis

microarray analysis

immunohistochemistry staining method

laboratory biomarker analysis

Heithem M. El-Hodiri, PhD

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to brain tumors.

PURPOSE: This research studies gene expression and location in samples from patients with brain tumors.

OBJECTIVES:

* To determine the expression and subcellular localization of nei endonuclease VIII-like 3 (NEIL3) in brain tumors.

OUTLINE: Tissue microarray samples are analyzed for NEIL3 expression and subcellular localization by immunohistochemical methods.

Studying Gene Expression and Location in Samples From Patients With Brain Tumors

Expression and Subcellular Localization of NEIL3 in Tumors

National Cancer Institute (NCI)

Children's Oncology Group

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Adenocarcinoma of Lung

Adenocarcinoma, Bronchiolo-Alveolar

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Docetaxel

Cisplatin

Lenograstim

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.

cisplatin

pegfilgrastim

erlotinib hydrochloride

polymorphism analysis

pharmacogenomic studies

docetaxel

William Petty

This phase II trial is studying how well docetaxel given together with cisplatin and pegfilgrastim followed by erlotinib hydrochloride works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dose-dense combination chemotherapy together with pegfilgrastim and erlotinib hydrochloride may kill more tumor cells

PRIMARY OBJECTIVES:

I. To determine if this regimen improves the time-to-progression for patients with advanced non-small cell lung cancer (NSCLC) compared to historical controls.

SECONDARY OBJECTIVES:

I. To assess response rate and median survival. II. To evaluate tumor biomarkers that could predict response and survival for patients treated with this regimen including endothelial growth factor receptor (EGFR) expression, EGFR Fluorescence in situ hybridization (FISH), and k-ras mutations.

III. To evaluate genetic polymorphisms as markers of response and survival for patients treated with this regimen including polymorphisms in XPD, XRCC1, XRCC3, and cyclin D1.

OUTLINE:

Patients receive docetaxel intravenously (IV) over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive erlotinib hydrochloride orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and every 6 months for 2 years.

Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Phase II Study of Sequential Dose-Dense Chemotherapy and Dose-Intense Erlotinib for the Initial Treatment of Advanced Non-Small Cell Lung Cancer

Determined using RECIST. Estimated using the Kaplan-Meier method. Log-rank tests will be used to test for differences and Cox proportional hazards regression modeling will be used to adjust for patient demographics and characteristics such as smoking status at baseline (actively/non-actively smoking). Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Pre-specified that data is only presented for the subgroups "Low Cyclin D1" and "High Cyclin D1".

OSI Pharmaceuticals

Wake Forest University Health Sciences

44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.

Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. William J. Petty

Time to Progression

Progressive disease

Stable disease

Partial response

Low Cyclin D1

High Cyclin D1

Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood

Median Survival Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood

Overall Study

Small Cell Lung Carcinoma

Small Cell Lung Cancer

loss of heterozygosity analysis

mutation analysis

polymerase chain reaction

biologic sample preservation procedure

medical chart review

questionnaire administration

evaluation of cancer risk factors

Penella J. Woll, MD, PhD

RATIONALE: Gathering information about genetic and environmental factors from patients with lung cancer and their partners and first-degree relatives may help doctors learn more about the disease.

PURPOSE: This clinical trial is looking at the patterns, causes, and control of disease in patients with lung cancer in the North Trent (England) region.

OBJECTIVES:

Primary

* To establish a resource bank of high quality genomic and plasma DNA and tumor and serum samples linked to clinical data obtained from detailed family history and lifestyle questionnaires from patients with lung cancer and from their partners and first-degree relatives for genetic epidemiology studies of lung cancer.

Secondary

* To study single nucleotide polymorphisms for candidate lung cancer susceptibility genes in genomic DNA samples from patients with lung cancer and from their partners and first-degree relatives.
* To study genetic changes of lung cancer in plasma DNA samples from patients with lung cancer and from their partners and first-degree relatives.

OUTLINE: This is a multicenter study.

Patients and their partners complete a detailed, interview-based questionnaire to assess their environmental risk factors for cancer. Information on past medical, social, occupational, and smoking history as well as family history, including any malignancies diagnosed and subsequent causes of death, is collected. First-degree relatives of patients complete an interview-based questionnaire about smoking, occupational, and cancer history. Relatives of patients' partners complete a telephone-administered questionnaire only.

Medical records of patients are reviewed to obtain information on pathological diagnosis and laboratory number, date of diagnosis, stage of disease, performance status, co-morbidities, and treatment plan. Medical records of partners may also be reviewed to obtain information on the incidence of smoking-related malignancies (i.e., cancer of the lung, larynx, esophagus, stomach, bladder, or head and neck).

Patients and their partners and first-degree relatives undergo blood sample collection for laboratory studies. Previously collected tumor samples are obtained from patients. Plasma DNA, lymphocyte DNA, and tumor DNA are analyzed by polymerase chain reaction (PCR) to identify loss of heterozygosity (LOH) between genomic (lymphocyte) DNA and the tumor and plasma DNA. Specific tumor-associated mutations are also analyzed by real-time PCR. Single nucleotide polymorphism studies, including common gene polymorphisms (metabolic genes, DNA repair genes, and tumor suppressor genes), in lung cancer families are also conducted.

A statistical model will be developed for future analysis and will include correlations in genetic alterations in DNA isolated from tumor and plasma, familial aggregation studies, and genetic analysis studies.

PROJECTED ACCRUAL: A total of 2,000 participants (500 patients and 1,500 partners and first-degree relatives \[controls\]) will be accrued for this study.

Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region

Resource for the Study of Lung Cancer Epidemiology in North Trent

Cancer Research Centre at Weston Park Hospital

Digestive System Diseases

Esophageal Neoplasms

Barrett Esophagus

Precancerous Conditions

Disease Susceptibility

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

comparative genomic hybridization

study of high risk factors

Rebecca Fitzgerald, MD

RATIONALE: Learning about how often heartburn and other risk factors occur in brothers and sisters and other family members of patients with Barrett's esophagus may help identify other individuals at risk and identify genes for Barrett's esophagus.

PURPOSE: This clinical trial is studying genes for Barrett's esophagus in brothers and sisters.

OBJECTIVES:

Primary

* To investigate the familial incidence of heartburn and Barrett's esophagus in first and second degree relatives of patients with Barrett's esophagus in the United Kingdom.
* To determine susceptibility genes for Barrett's esophagus in affected sibling pairs.
* To examine gene-environment interactions, such as smoking, alcohol, and Helicobacter pylori status, on familial susceptibility to heartburn and Barrett's esophagus.

Secondary

* To compare the mortality from esophageal adenocarcinoma in family members with heartburn and Barrett's esophagus with deaths from other causes.

OUTLINE: This is a multicenter study.

Patients complete a family history questionnaire. Epidemiological data is also collected about environmental exposures, such as smoking and alcohol history. Any siblings or other living family members affected by heartburn identified from this survey are then contacted to validate their symptoms/diagnoses and to collect other relevant epidemiological data. Family members with heartburn are offered a screening endoscopy for the presence of Barrett's esophagus. In the absence of an endoscopy, a symptom nomogram predictive for the presence of Barrett's esophagus is used.

Patients and their siblings, as well as any other willing family member (affected or non-affected) are asked to have a blood sample (EDTA tube for genetic analysis and a serum sample for Helicobacter pylori status) taken by their physician. Genomic DNA is extracted from lymphocytes and a genome-wide scan is performed using a standard marker set. A computer program is used to verify sibling relationships. Individuals not found to be full siblings are excluded from subsequent analyses. Maximum likelihood score (MLS) and the nonparametric linkage score (NPL) is used to estimate the degree of linkage.

All study participants are flagged with the National Health Service (NHS) Central Register to ascertain the future mortality from esophageal adenocarcinoma compared with deaths from other causes.

PROJECTED ACCRUAL: A total of 200 sibling pairs will be accrued for this study.

Studying Genes for Barrett's Esophagus in Brothers and Sisters

A Sibling Pair Study To Identify Barrett's Oesophagus Susceptibility Genes

Medical Research Council

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Studying Gene Expression and Location in Samples From Patients With Brain Tumors	NCT01585389	Brain and Centr...	gene expression... genetic linkage... microarray anal... immunohistochem... laboratory biom...	-	Children's Oncology Group
Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer	NCT01557959	Adenocarcinoma ... Adenosquamous C... Bronchoalveolar... Large Cell Lung... Non-small Cell ... Recurrent Non-s... Squamous Cell L... Stage IIIB Non-... Stage IV Non-sm...	cisplatin pegfilgrastim erlotinib hydro... laboratory biom... polymorphism an... pharmacogenomic... genetic linkage... docetaxel	18 Years -	Wake Forest University Health Sciences
Studying Gene Expression and Location in Samples From Patients With Brain Tumors	NCT01585389	Brain and Centr...	gene expression... genetic linkage... microarray anal... immunohistochem... laboratory biom...	-	Children's Oncology Group
Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region	NCT00693836	Lung Cancer	genetic linkage... loss of heteroz... mutation analys... polymerase chai... polymorphism an... biologic sample... medical chart r... questionnaire a... evaluation of c...	18 Years -	National Cancer Institute (NCI)
Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region	NCT00693836	Lung Cancer	genetic linkage... loss of heteroz... mutation analys... polymerase chai... polymorphism an... biologic sample... medical chart r... questionnaire a... evaluation of c...	18 Years -	National Cancer Institute (NCI)
Studying Genes for Barrett's Esophagus in Brothers and Sisters	NCT00516347	Esophageal Canc... Precancerous Co...	comparative gen... genetic linkage... laboratory biom... questionnaire a... study of high r...	-	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for genetic linkage analysis