Ignite Creation Date:
2024-05-05 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00736814
Status:
UNKNOWN
Last Update Posted:
2011-02-24
First Post:
2008-08-15
Brief Title:
First-Line Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Sponsor:
Yonsei University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Genotype-driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 RRM1 as First-line Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2009-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells It is not yet known which combination chemotherapy regimen is most effective in treating non-small cell lung cancer
PURPOSE This randomized phase II trial is comparing different combination chemotherapy regimens to see how well they work as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer that cannot be removed by surgery
PURPOSE This randomized phase II trial is comparing different combination chemotherapy regimens to see how well they work as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer that cannot be removed by surgery
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SANOFI-AVENTIS-YONSEI-4-2008-0 | None | None | None |
| YONSEI-4-2008-0132 | None | None | None |