Pemetrexed in Advanced Non-small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Istituto Clinico Humanitas.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT01193959
First received: August 26, 2010
Last updated: October 11, 2010
Last verified: September 2010
  Purpose

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
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of each biomarker with clinico-pathological features: histology, gender, age, smoking status, response to previous chemotherapy. [ Time Frame: one year ] [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01193959

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

No publications provided

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 26, 2014