Clinical Trials Logo
  1. Home
  2. Lung Cancer
  3. NCT00897533
  4. Details
NCT00897533 Clinical Trial

Development of a Model to Predict Progression-Free Survival After Erlotinib in Patients With Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:
Development of a Model to Predict Progression Free Survival After Treatment With Erlotinib in E3503

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00897533
Other study ID # CDR0000543981
Secondary ID ECOG-E3503T1
Status Completed
Phase N/A
First received May 9, 2009
Last updated May 17, 2017
Start date April 13, 2007
Est. completion date April 13, 2008

Study information
Verified date May 2017
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment with erlotinib.

PURPOSE: This laboratory study is developing a model to predict progression-free survival after erlotinib in patients with non-small cell lung cancer.

Description:

OBJECTIVES:

- Assess mesenchymal and epithelial markers in tissues from patients with non-small cell lung cancer treated with erlotinib hydrochloride on clinical trial ECOG-E3503.

- Determine the loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) in these patients.

- Assess whether mesenchymal and epithelial markers are predictive of progression-free survival (PFS) of these patients.

- Identify a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS of these patients.

OUTLINE: Tissue samples are analyzed by whole genome mapping for single nucleotide polymorphism (SNP) rate and by signal detection rate and by quantitative immunohistochemistry for mesenchymal (vimentin/cytokeratin) and epithelial (E-cadherin) marker transitions. After biomarker identification and gene mapping are complete, a model to predict progression-free survival in these patients is developed.

PROJECTED ACCRUAL: A total of 137 samples will be accrued for this study.

Recruitment information / eligibility
Status Completed
Enrollment 137
Est. completion date April 13, 2008
Est. primary completion date April 13, 2008
Accepts healthy volunteers No
Gender All
Age group N/A to 120 Years
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of non-small cell lung cancer, including any of the following subtypes:

- Adenocarcinoma

- Squamous cell carcinoma

- Bronchoalveolar carcinoma

- Carcinoid

- Stage IIIB or IV or recurrent disease

- Must have received treatment with erlotinib hydrochloride on clinical trial ECOG-E3503

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• gene mapping

• polymorphism analysis

Other:
• diagnostic laboratory biomarker analysis

• immunohistochemistry staining method

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

References & Publications (1)

Amann JM, Lee JW, Roder H, Brahmer J, Gonzalez A, Schiller JH, Carbone DP. Genetic and proteomic features associated with survival after treatment with erlotinib in first-line therapy of non-small cell lung cancer in Eastern Cooperative Oncology Group 350 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mesenchymal and epithelial markers Mesenchymal and epithelial markers 1 month
Primary Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers 1 month
Primary Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers 1 month
Primary Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS 1 month
See also
  Status Clinical Trial Phase
Completed NCT03918538 - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors N/A
Recruiting NCT05078918 - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors N/A
Active, not recruiting NCT04548830 - Safety of Lung Cryobiopsy in People With Cancer Phase 2
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05898594 - Lung Cancer Screening in High-risk Black Women N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Terminated NCT03275688 - NanoSpectrometer Biomarker Discovery and Confirmation Study
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT06052449 - Assessing Social Determinants of Health to Increase Cancer Screening N/A
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk