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Pemetrexed in Advanced Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01193959
Recruitment Status : Unknown
Verified September 2010 by Istituto Clinico Humanitas.
Recruitment status was:  Active, not recruiting
First Posted : September 2, 2010
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Istituto Clinico Humanitas

Tracking Information
First Submitted Date August 26, 2010
First Posted Date September 2, 2010
Last Update Posted Date October 13, 2010
Study Start Date September 2010
Estimated Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2010)
Association of each biomarker with treatment outcome in terms of response rate, time to progression, overall survival. [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 1, 2010)
Association of each biomarker with clinico-pathological features: histology, gender, age, smoking status, response to previous chemotherapy. [ Time Frame: one year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pemetrexed in Advanced Non-small Cell Lung Cancer
Official Title Retrospective Study of Molecular Predictors of Sensitivity and Resistance to Pemetrexed in Advanced Non-Small Cell Lung Cancer
Brief Summary 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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Non-small cell lung cancer patients treated with single agent pemetrexed
Condition Non-small Cell Lung Cancer (NSCLC)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 1, 2010)
33
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2011
Estimated Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01193959
Other Study ID Numbers ONC/OSS-02/2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Armando Santoro, MD, Istituto Clinico Humanitas
Study Sponsor Istituto Clinico Humanitas
Collaborators Not Provided
Investigators
Principal Investigator: Armando SANTORO, MD Istituto Clinico Humanitas
PRS Account Istituto Clinico Humanitas
Verification Date September 2010