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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
Recruitment status was: Active, not recruiting
Sponsor:
Istituto Clinico Humanitas
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT01193959
First received: August 26, 2010
Last updated: October 11, 2010
Last verified: September 2010
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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:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Pemetrexed
U.S. FDA Resources
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) |
Eligibility| 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
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
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
| 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 |
Additional relevant MeSH terms:
|
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 Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on September 19, 2017