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

History of Changes

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:

MedlinePlus related topics: Lung Cancer

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 ] [ 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms	Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

ClinicalTrials.gov processed this record on March 03, 2015

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