Genotype-Driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy
NCT ID: NCT01648517
Last Updated: 2017-11-28
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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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2012-07-27
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Genomic-driven dual agent chemotherapy Chemotherapy will consist of the assigned two drugs according to ERCC1 and RRM1 mRNA expression level A1: docetaxel + vinorelbine (DV) A2: gemcitabine + vinorelbine (GV) A3: docetaxel + carboplatin (DC) A4: gemcitabine + carboplatin (GC)
chemotherapy
A1: docetaxel 60mg/m2 on Day 1 vinorelbine 20mg/m2 on Day 1 and Day 8 (DV) A2: gemcitabine 1000mg/m2 on Day 1 vinorelbine 25mg/m2 on Day 1 and Day 8 (GV) A3: docetaxel 75mg/m2 on Day 1 carboplatin AUC5 on Day 1 (DC) A4: gemcitabine 1000mg/m2 on Day 1 and 8 carboplatin AUC5 on Day 1 (GC)
Arm B
standard of care All control arm patients received standard platinum-based doublet chemotherapy with docetaxel plus carboplatin
chemotherapy
Drug: Docetaxel 75mg/m2 IV on Day 1 Drug: Carboplatin AUC5 IV on Day 1
Interventions
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chemotherapy
A1: docetaxel 60mg/m2 on Day 1 vinorelbine 20mg/m2 on Day 1 and Day 8 (DV) A2: gemcitabine 1000mg/m2 on Day 1 vinorelbine 25mg/m2 on Day 1 and Day 8 (GV) A3: docetaxel 75mg/m2 on Day 1 carboplatin AUC5 on Day 1 (DC) A4: gemcitabine 1000mg/m2 on Day 1 and 8 carboplatin AUC5 on Day 1 (GC)
chemotherapy
Drug: Docetaxel 75mg/m2 IV on Day 1 Drug: Carboplatin AUC5 IV on Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chemotherapy naïve patient (Previous adjuvant or neoadjuvant chemotherapy allowed if the last dose was administered equal to or greater than 6 months ago.)
3. Age \> 18
4. Performance status 0 to 2 by Eastern Cooperative Oncology Group (ECOG) criteria
5. At least one measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST)
6. Adequate organ functions (assessed within 14 days of starting treatment) 1) Bone marrow: Absolute neutrophil count ≥ 1,500/mm³, Platelet count ≥ 100,000/mm³, Hemoglobin ≥ 9.0 mg/dL 2) Liver: Total bilirubin ≤ 1.5 x ULN; aspartic transaminase (AST) and alanine transaminase (ALT), alkaline phosphatase(ALP) ≤ 2.5 x ULN 3) Kidney: Serum creatinine ≤ 1.5 x ULN
7. Signed informed consent document
Exclusion Criteria
2. Prior systemic chemotherapy or immunotherapy for advanced NSCLC.
3. Presence of uncontrolled brain or leptomeningeal metastases
4. Prior radiotherapy within 3 weeks of starting treatment
5. Peripheral neuropathy equal to or greater than grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
6. Pregnant or lactating
7. Absolute contraindication of corticosteroid use
8. Patients with a history of severe hypersensitivity reaction to docetaxel, carboplatin, vinorelbine or gemcitabine
18 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severance Hospital
Seoul, , South Korea
Countries
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References
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Heo SJ, Jung I, Lee CK, Kim JH, Lim SM, Moon YW, Shim HS, Jeong J, Kim JH, Kim HR, Cho BC. A randomized phase II trial of ERCC1 and RRM1 mRNA expression-based chemotherapy versus docetaxel/carboplatin in advanced non-small cell lung cancer. Cancer Chemother Pharmacol. 2016 Mar;77(3):539-48. doi: 10.1007/s00280-016-2968-z. Epub 2016 Jan 25.
Other Identifiers
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4-2008-0132
Identifier Type: -
Identifier Source: org_study_id