Individualized Therapy Based of Tumoral mRNA Levels of ERCC1, RRM1 and BRCA1 in Advanced Non-Small-Cell Lung Cancer
NCT ID: NCT00705549
Last Updated: 2013-02-13
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
88 participants
INTERVENTIONAL
2008-02-29
2011-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma
NCT00617656
Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib
NCT02604342
Combination of Erlotinib and Bevacizumab as Second-line Treatment in Patients With Non-small Cell Lung Cancer
NCT00749567
Phase IV Study of Tarceva in Patients With Advanced Stage IIIB/ IV Non-small Cell Lung Cancer (NSCLC)
NCT01951755
A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel.
NCT00386555
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The selection of appropriate treatment for individual patients remains a challenge in clinical oncology, particularly in the advanced disease. Several lines of evidence indicate that polymorphisms, gene transcripts and gene mutations can play a predictive role and can be used to tailor chemotherapy in different subgroups of cancer patients. There are evidence lead us to use the expression levels of ERCC1 by the tumor as a molecular marker for customized chemotherapy. Another gene, the BRCA1 has a crucial role in DNA repair, since it is implicated in transcription-coupled nucleotide excision repair (TC-NER), leading to radio- and chemo-resistance. RRM1,localized in 11p15.5,also acts as a putative tumor suppressor gene. RRM1 overexpression was related to gemcitabine resistance in human oropharyngeal epidermoid carcinoma KB cells as well as in patients with NSCLC. For those reason we decided to conduct a prospective pilot phase II trial, in patients with wet stage IIIb and IV NSCLC using chemotherapy regimens which will be defined according to the pharmacogenomic profile (tumoral expression of ERCC1, BRCA1 and RRM1) of the tumor cells.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Gemzar/Cisplatin
Gemcitabine
Gemcitabine I.V at the dose of 1000mg/m2 on Day 1 and Day 8
Cisplatin
Cisplatin I.V at the dose of 75mg/m2 on Day 1
2
Taxotere/Cisplatin
Cisplatin
Cisplatin I.V at the dose of 75mg/m2 on Day 1
Docetaxel
Docetaxel I.V at the dose of 75mg/m2 on Day 1
3
Cisplatin/Navelbine metronomic
Cisplatin
Cisplatin I.V at the dose of 80mg/m2 on Day 1
Vinorelbine
Vinorelbine per os 50mg every Monday, Wednesday and Friday
4
Taxotere/Gemzar
Gemcitabine
Gemcitabine I.V at the dose of 1000mg/m2 on Day 1 and Day 8
Docetaxel
Docetaxel I.V at the dose of 75mg/m2 on Day 1
5
Gemzar
Gemcitabine
Gemcitabine I.V at the dose of 1000mg/m2 on Day 1 and Day 8
6
Taxotere
Docetaxel
Docetaxel I.V at the dose of 75mg/m2 on Day 1
7
Navelbine metronomic
Vinorelbine
Vinorelbine per os 50mg every Monday, Wednesday and Friday
8
Alimta/Cisplatin
Cisplatin
Cisplatin I.V at the dose of 75mg/m2 on Day 1
Pemetrexate
Pemetrexate I.V 500mg/m2 on Day 1
9
Alimta/Gemzar
Gemcitabine
Gemcitabine I.V at the dose of 1000mg/m2 on Day 1 and Day 8
Pemetrexate
Pemetrexate I.V 500mg/m2 on Day 1
10
Taxotere
Docetaxel
Docetaxel I.V at the dose of 75mg/m2 on Day 1
11
Alimta
Pemetrexate
Pemetrexate I.V 500mg/m2 on Day 1
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gemcitabine
Gemcitabine I.V at the dose of 1000mg/m2 on Day 1 and Day 8
Cisplatin
Cisplatin I.V at the dose of 75mg/m2 on Day 1
Docetaxel
Docetaxel I.V at the dose of 75mg/m2 on Day 1
Cisplatin
Cisplatin I.V at the dose of 80mg/m2 on Day 1
Vinorelbine
Vinorelbine per os 50mg every Monday, Wednesday and Friday
Pemetrexate
Pemetrexate I.V 500mg/m2 on Day 1
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adequate Formalin Fixed Paraffin Embedded tumor sample provided for molecular analysis
* No previous anticancer treatment for metastatic/advanced disease. Patients who received prior adjuvant chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy.
* Age above 18 years
* Performance status (ECOG) 0-2
* Life expectancy \>= 3 months
* Effective contraception for both male and female subjects if the risk of conception exists
* Adequate hematologic parameters (absolute neutrophil count \>= 1.5x109/L and platelets \>= 100x109/L), creatinine (GFR\>= 60ml/min) and total bilirubin \< 1.5 times the upper limit of normal; aspartate and alanine aminotransferase \< 2,5 times the upper limit of normal
* All patients will have to sign written informed consent in order to participate in the study
Exclusion Criteria
* Active infection or malnutrition (loss of more than 20% of the body weight)
* Known hypersensitivity reaction to any of the component of the treatment
* Concurrent or previous chronic systemic immune therapy
* Pregnancy (absence to be confirmed by ß-HCG test) or lactation period
* Known alcohol/drug abuse
* Legal incapacity or limited legal capacity
* Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
* A second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma
* Previous radiotherapy to the target lesions. Patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields
* Patients with severe cardiac dysfunction, unstable angina petrosis, or high risk of uncontrolled arrhythmia
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital of Crete
OTHER
Hellenic Oncology Research Group
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John Souglakos, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Crete, Dep of Medical Oncology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University General Hospital of Alexandroupolis, Dept. of Medical Oncology
Alexandroupoli, , Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, , Greece
401 Military Hospital, Medical Oncology Unit
Athens, , Greece
Air Forces Military Hospital, Dep of Medical Oncology
Athens, , Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, , Greece
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
Athens, , Greece
Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
Athens, , Greece
"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Piraeus, , Greece
"Theagenion" Anticancer Hospital of Thessaloniki
Thessaloniki, , Greece
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CT/07.23
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.