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Pemetrexed in Advanced Non-small Cell Lung Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Istituto Clinico Humanitas.
Recruitment status was:  Active, not recruiting
Information provided by:
Istituto Clinico Humanitas Identifier:
First received: August 26, 2010
Last updated: October 11, 2010
Last verified: September 2010
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).

Non-small Cell Lung Cancer (NSCLC)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Istituto Clinico Humanitas:

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

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

Estimated Enrollment: 33
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
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Please refer to this study by its identifier: NCT01193959

Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Principal Investigator: Armando SANTORO, MD Istituto Clinico Humanitas
  More Information

Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas Identifier: NCT01193959     History of Changes
Other Study ID Numbers: ONC/OSS-02/2010
Study First Received: August 26, 2010
Last Updated: October 11, 2010

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on April 24, 2017