Genotype-driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy
18 Years
N/A
Both
Lung Cancer
Trial Information
Genotype-driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy
OBJECTIVES:
- To assess treatment outcomes of adjuvant chemotherapy based on ERCC1 and RRM1 mRNA
levels in patients with stage IIIB or IV non-small cell lung cancer.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
RNA is isolated from pretreatment biopsy samples and analyzed with reverse transcriptase-PCR
(RT-PCR) assays to determine ERCC1 and RRM1 mRNA expression.
- Arm I: Patients receive standard chemotherapy comprising docetaxel IV and carboplatin
IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients are treated according to ERCC1 and RRM1 mRNA expression levels as
determined by RT-PCR.
- Genotype A1 (high ERCC1 and high RRM1 mRNA levels): Patients receive non-platinum
doublet chemotherapy comprising docetaxel and vinorelbine ditartrate IV on days 1
and 15. Treatment repeats every 4 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity.
- Genotype A2 (high ERCC1 and low RRM1 mRNA levels): Patients receive non-platinum
doublet chemotherapy comprising gemcitabine hydrochloride IV and vinorelbine
ditartrate IV on days 1 and 8. Treatment repeats every 3 weeks for 4 courses in
the absence of disease progression or unacceptable toxicity.
- Genotype B1 (low ERCC1 and high RRM1 mRNA levels): Patients receive platinum
doublet chemotherapy comprising docetaxel IV and carboplatin IV on day 1.
Treatment repeats every 3 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity.
- Genotype B2 (low ERCC1 and low RRM1 mRNA levels): Patients receive platinum
doublet chemotherapy comprising gemcitabine hydrochloride IV on days 1 and 8 and
carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the
absence of disease progression or unacceptable toxicity.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven or radiologically and clinically suspected stage IIIB (with
malignant pleural effusion) or IV non-small cell lung cancer
- Unresectable disease
- At least 1 measurable lesion (> 10 mm with spiral CT scan or > 20 mm with
conventional CT scan)
- No symptomatic or untreated brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 12 weeks
- ANC ≥ 1,500/mm³
- Hemoglobin > 9.0 g/dL
- Platelet count ≥ 100,000/mm³
- AST and ALT < 2 times upper limit of normal (ULN)
- Bilirubin < 1.5 mg/dL
- Creatinine < 1.5 times ULN
- Not pregnant or nursing
- No serious uncontrolled systemic intercurrent illness, including any of the
following:
- Acute myocardial infarction
- Uncontrolled arrhythmia
- Uncontrolled heart failure
- Sepsis
- Poorly controlled diabetes
- No other malignancy within the last 5 years, except for carcinoma in situ of the
cervix or nonmelanomatous carcinoma of the skin
PRIOR CONCURRENT THERAPY:
- At least 3 weeks since prior radiotherapy, including cranial irradiation
- At least 3 weeks since prior major surgery
- No prior systemic chemotherapy except adjuvant chemotherapy provided it was completed
more than 12 months ago
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate (complete and partial responses)
Safety Issue:
No
Principal Investigator
Byung Chul Cho
Investigator Role:
Principal Investigator
Investigator Affiliation:
Yonsei University
Authority:
Unspecified
Study ID:
CDR0000609880
NCT ID:
NCT00736814
Start Date:
June 2008
Completion Date:
Related Keywords:
- Lung Cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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