First-Line Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Phase 2

• Conditions: Lung Cancer
• Interventions: Drug: carboplatin; Drug: docetaxel; Drug: gemcitabine hydrochloride; Drug: vinorelbine tartrate

• Registration Number: NCT00736814
• Lead Sponsor: Yonsei University

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.

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Status Verified: 2009-08
• Last Update Submitted: 2011-02-23
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm II, Genotype A2	vinorelbine tartrate	Patients receive gemcitabine hydrochloride and vinorelbine ditartrate.
Arm I	carboplatin	Patients receive standard chemotherapy of docetaxel and carboplatin.
Arm II, Genotype A1	docetaxel	Patients receive docetaxel and vinorelbine ditartrate.
Arm II, Genotype A1	vinorelbine tartrate	Patients receive docetaxel and vinorelbine ditartrate.
Arm II, Genotype A2	gemcitabine hydrochloride	Patients receive gemcitabine hydrochloride and vinorelbine ditartrate.
Arm II, Genotype B1	carboplatin	Patients receive docetaxel and carboplatin.
Arm II, Genotype B1	docetaxel	Patients receive docetaxel and carboplatin.
Arm II, Genotype B2	carboplatin	Patients receive gemcitabine hydrochloride and carboplatin.
Arm II, Genotype B2	gemcitabine hydrochloride	Patients receive gemcitabine hydrochloride and carboplatin.
Arm I	docetaxel	Patients receive standard chemotherapy of docetaxel and carboplatin.

Primary Outcome Measures

Name	Time	Method
Response rate (complete and partial responses)

Secondary Outcome Measures

Name	Time	Method
Disease control rate
Response duration
Progression-free survival
Overall survival
Toxicity

Trial Locations

Locations (1)

Yonsei Cancer Center at Yonsei University Medical Center; 🇰🇷 Seoul, Korea, Republic of