Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2018-11-01
2019-11-30
Brief Summary
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* 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
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. ECOG PS 0-2.
3. Chemotherapy naïve.
4. Age \>18 years.
5. Adequate bone marrow reserve.
Exclusion Criteria
2. 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).
3. Inadequate renal function (creatinine \> 1.25 times ULN, creatinine clearance \< 50mL/min).
4. Serious comorbid systemic disorder incompatible with the study.
5. 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).
6. Pregnancy
18 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Yara Sayed Abdulwahid
Clinical Pharmacist
Locations
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Ain Shams University's Hospital
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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The role of the mammalian copper transporter 1 in the cellular accumulation of platinum-based drugs.
Other Identifiers
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ASU309
Identifier Type: -
Identifier Source: org_study_id
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