Molecular Predictors of Pemetrexed and Carboplatin Response in Tumor Samples of a Series of Malignant Pleural Mesothelioma (MPM) Patients and Genotyping for the TSER Polymorphism - Full Text View

Sponsored by:	Istituto Clinico Humanitas
Information provided by:	Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:	NCT00867711

Purpose

The aim of the present study is to investigate the molecular predictors of pemetrexed and carboplatin response in tumor samples of a series of MPM patients extracting the DNA and genotyping for the TSER polymorphism.

Condition
Malignant Pleural Mesothelioma

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Pharmacogenetics of Pemetrexed and Carboplatin in Malignant Pleural Mesothelioma Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma

Drug Information available for: Carboplatin Pemetrexed

U.S. FDA Resources

Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:

Evaluate the expression and allelic variants of a panel of candidate genes involved in the resistance to drugs, the genome wide copy number changes in patients treated with drugs combination in the first line [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate retrospectively the correlation between gene expression and polymorphisms in candidate genes and array-CGH data, immunohistochemistry data, and clinical data. [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

The paraffin-embedded tumor specimens of patients will be collected. The tumor RNA and DNA will be extracted and genotyping, gene expression and gene copy number analyses will be performed with validated PCR and array-CGH techniques.

Estimated Enrollment:	100
Study Start Date:	January 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Detailed Description:

Malignant pleural mesothelioma (MPM) is an aggressive tumor that usually has a poor prognosis. The combination of cisplatin and pemetrexed has recently become the standard of care in the first-line treatment of MPM. For patients who are unfit to receive a cisplatin-based chemotherapy, pemetrexed alone [7] or combined with carboplatin [8] has been proposed as an alternative treatment choice. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients.

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

Malignant Pleural Mesothelioma patients treated with carboplatin and pemetrexed

Criteria

Inclusion Criteria:

Availability of tumor tissue.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867711

Locations

Italy, Milano
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:	Istituto Clinico Humanitas ( Armando Santoro, MD )
Study ID Numbers:	ONC/OSS-04/2008
Study First Received:	March 23, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00867711 History of Changes
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Pemetrexed
Mesothelioma
Carboplatin
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Neoplasms, Mesothelial
Therapeutic Uses

Mesothelioma
Carboplatin
Adenoma
Pharmacologic Actions
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 25, 2009