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Pemetrexed in Advanced Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01193959
Recruitment Status : Unknown
Verified September 2010 by Istituto Clinico Humanitas.
Recruitment status was:  Active, not recruiting
First Posted : September 2, 2010
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Istituto Clinico Humanitas

Study Description
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Brief 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).

Condition or disease
Non-small Cell Lung Cancer (NSCLC)

Study Design
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Study Type : Observational
Estimated Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of Molecular Predictors of Sensitivity and Resistance to Pemetrexed in Advanced Non-Small Cell Lung Cancer
Study Start Date : September 2010
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2011

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Association of each biomarker with treatment outcome in terms of response rate, time to progression, overall survival. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Association of each biomarker with clinico-pathological features: histology, gender, age, smoking status, response to previous chemotherapy. [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-small cell lung cancer patients treated with single agent pemetrexed
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193959


Locations
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Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Armando SANTORO, MD Istituto Clinico Humanitas
More Information
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Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT01193959    
Other Study ID Numbers: ONC/OSS-02/2010
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms