- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03791151
Pharmacogenetics in Non Small Cell Lung Cancer
Effect of Copper Transporter-1 Genetic Polymorphism on Platinum Based Chemotherapy Response in Advanced Non-Small Cell Lung Cancer Patients
Study the effect of genetic polymorphism in the membrane copper transporter 1 protein [CTR1; encoded by the solute carrier family 31 member 1 gene (SLC31A1 gene)] and its genetic expression levels on the clinical outcome of cisplatin-based regimen used in the treatment of Non-Small Cell Lung Cancer (NSCLC) in terms of :
- Treatment response : partial response (PR) / complete response (CR) and Progression-free survival (PFS)
- Treatment resistance : stationary disease (SD) or progressed disease
- Frequency and severity of regimen related toxicity
Study Overview
Status
Conditions
Detailed Description
The cisplatin-based regimen is an effective treatment for advanced NSCLC, showing significant beneficial outcomes such as prolong survival, improve clinical symptoms, and improve quality of life (QOL) . Although platinum-based therapy shows several benefits, but the five-year survival rate still less than 20%.
Pt resistance is an inevitable occurrence with rare exception. Aside from germ cell tumors, metastatic solid tumors are generally thought to be incurable with cytotoxic chemotherapy due to the development of resistance and subsequent disease progression.
Despite the multifactorial nature of Cisplatin resistance, intracellular accumulation of Pt appears to be a major source of drug resistance . Reduced intracellular drug accumulation is one of the most consistently identified features of cisplatin-resistant cells.
Many evidences indicated that alteration of copper transporter protein 1 (CTR1) which is the major plasma membrane transporter responsible for platinum uptake, was associated with platinum sensitivity and toxicity.
Genetic polymorphisms of CTR1 also have effects to platinum treatment response. Therefore, CTR1 might be a potential prognostic factor for survival in cancer patients underwent chemotherapy and a treatment target for overcoming platinum resistance.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11566
- Recruiting
- Ain Shams University's Hospital
-
Contact:
- Ahmed A Nagy, lecturer
- Phone Number: +2 010273373313
- Email: ahmedalynagy@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Newly diagnosed with immunohistochemically and pathologically confirmed non- small cell lung cancer (NSCLC).
- ECOG PS 0-2.
- Chemotherapy naïve.
- Age >18 years.
- Adequate bone marrow reserve.
Exclusion Criteria:
- Presence of central nervous system metastases.
- Inadequate liver function (bilirubin > 1.5 times upper normal limit [ULN] and alanine transaminase [ALT] or aspartate transaminase [AST] > 3.0 ULN or up to 5.0 UNL in the presence of hepatic metastases).
- Inadequate renal function (creatinine > 1.25 times ULN, creatinine clearance < 50mL/min).
- Serious comorbid systemic disorder incompatible with the study.
- Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence).
- Pregnancy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response and resistance
Time Frame: 1 year
|
will be evaluated after the third (initial evaluation response) and the sixth (confirmation of initial response) chemotherapy cycle according to the new Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: 1.5 years
|
defined as the time from day 1 of chemotherapy to the day of documented disease progression or death.
|
1.5 years
|
Regimen related toxicity
Time Frame: 1.5 years
|
1. Hematologic toxicity (anemia, neutropenia, and thrombocytopenia) 2. Nephrotoxicity 3. Ototoxicity 4. Neurotoxicity
|
1.5 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Blair BG, Larson CA, Safaei R, Howell SB. Copper transporter 2 regulates the cellular accumulation and cytotoxicity of Cisplatin and Carboplatin. Clin Cancer Res. 2009 Jul 1;15(13):4312-21. doi: 10.1158/1078-0432.CCR-09-0311. Epub 2009 Jun 9.
- Roco A, Cayun J, Contreras S, Stojanova J, Quinones L. Can pharmacogenetics explain efficacy and safety of cisplatin pharmacotherapy? Front Genet. 2014 Nov 14;5:391. doi: 10.3389/fgene.2014.00391. eCollection 2014.
- Xu X, Ren H, Zhou B, Zhao Y, Yuan R, Ma R, Zhou H, Liu Z. Prediction of copper transport protein 1 (CTR1) genotype on severe cisplatin induced toxicity in non-small cell lung cancer (NSCLC) patients. Lung Cancer. 2012 Aug;77(2):438-42. doi: 10.1016/j.lungcan.2012.03.023. Epub 2012 Apr 17.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASU309
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States