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Genotype-Driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01648517
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : November 28, 2017
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
This is a prospective phase II trial, in patients with unresectable or metastatic NSCLC using chemotherapy regimens which will be defined according to the mRNA expression of ERCC1 and RRM1 of the tumor cells.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Carcinoma Drug: chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 27, 2012
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : June 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: 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)
Drug: 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)
Other Names:
  • Docetaxel - Taxotere
  • Vinorelbine: Sandoz vinorelbine
  • Carboplatin: Carplan
  • Gemcitabine: Gemzar

Active Comparator: Arm B
standard of care All control arm patients received standard platinum-based doublet chemotherapy with docetaxel plus carboplatin
Drug: chemotherapy
Drug: Docetaxel 75mg/m2 IV on Day 1 Drug: Carboplatin AUC5 IV on Day 1
Other Names:
  • Docetaxel - Taxotere
  • Carboplatin: Carplan

Primary Outcome Measures :
  1. overall Response Rate [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]

    ORR was assessed by tumor response evaluation according to RECIST 1.1 at every 8 weeks. Tumor assessments will continue about every 8 weeks until disease progression or initiation of subsequent anticancer treatment.

    (If PR or CR was first documented, confirmation assessment was done between 4 weeks and 8 weeks)

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: up to 4 years ]
  2. overall survival [ Time Frame: up to 4 years ]
  3. duration of response [ Time Frame: up to 4 years ]
  4. disease control rate [ Time Frame: up to 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed unresectable advanced or metastatic non-small cell lung cancer (NSCLC) (stage IIIB or IV)
  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:

  1. Clinically significant serious illness or medical condition (infection)
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01648517

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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yonsei University Identifier: NCT01648517     History of Changes
Other Study ID Numbers: 4-2008-0132
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Keywords provided by Yonsei University:
on-small cell lung carcinoma
chemotherapy naive patient
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic