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NCT01193959 Clinical Trial

Pemetrexed in Advanced Non-small Cell Lung Cancer

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:
Retrospective Study of Molecular Predictors of Sensitivity and Resistance to Pemetrexed in Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01193959
Other study ID # ONC/OSS-02/2010
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2010
Est. completion date June 2012

Study information
Verified date September 2022
Source Istituto Clinico Humanitas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Present study is aimed at investigating potential molecular predictors of sensitivity or resistance to single-agent pemetrexed in the ≥ second line setting in a large cohort of advanced non-small cell lung cancer (NSCLC) patients. The following biomarkers will be investigated with either immunohistochemistry, fluorescence in situ hybridization or genotyping: thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide ribonucleotide formyl transferase (GARFT), aminoimidazole carboxamide ribonucleotide formyltransferase (ATIC/AICARFT), epidermal growth factor receptor (EGFR), Kirsten rat sarcoma 2 viral oncogene homolog (KRAS), v-myc myelocytomatosis viral oncogene homolog (MYC) and phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA).

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date June 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically confirmed diagnosis of advanced non-small cell lung cancer - Tumor tissue available at our institution - Patients treated with single agent pemetrexed for metastatic disease - Availability of full clinical data Exclusion Criteria: - Cytological diagnosis of advanced Non-small cell lung cancer - Lack of tumor tissue at our institution - Lack of full clinical data

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Istituto Clinico Humanitas Rozzano Milano

Sponsors (1)
Lead Sponsor Collaborator
Armando Santoro, MD

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Association of each biomarker with treatment outcome in terms of response rate, time to progression, overall survival. one year
Secondary Association of each biomarker with clinico-pathological features: histology, gender, age, smoking status, response to previous chemotherapy. one year
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