Overview

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

Status:
Completed

Trial end date:
2015-06-30

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yonsei University

Treatments:

Carboplatin
Docetaxel
Gemcitabine
Vinblastine
Vinorelbine

Criteria

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