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Completed

NCT Number: NCT01648517

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

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.

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Key information

Conditions

Non-small Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed unresectable advanced or metastatic non-small cell lung cancer (NSCLC) (stage IIIB or IV)
  • Chemotherapy naïve patient (Previous adjuvant or neoadjuvant chemotherapy allowed if the last dose was administered equal to or greater than 6 months ago.)
  • Age > 18
  • Performance status 0 to 2 by Eastern Cooperative Oncology Group (ECOG) criteria
  • At least one measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST)
  • 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
  • Signed informed consent document

Exclusion criteria

  • Clinically significant serious illness or medical condition (infection)
  • Prior systemic chemotherapy or immunotherapy for advanced NSCLC.
  • Presence of uncontrolled brain or leptomeningeal metastases
  • Prior radiotherapy within 3 weeks of starting treatment
  • Peripheral neuropathy equal to or greater than grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
  • Pregnant or lactating
  • Absolute contraindication of corticosteroid use
  • Patients with a history of severe hypersensitivity reaction to docetaxel, carboplatin, vinorelbine or gemcitabine

Treatment and study plan

Chemotherapy

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 24, 2012
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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