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

NCT ID: NCT00736814

Last Updated: 2011-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive standard chemotherapy of docetaxel and carboplatin.

Group Type: ACTIVE_COMPARATOR

carboplatin

Intervention Type: DRUG

Given intravenously

docetaxel

Intervention Type: DRUG

Given intravenously

Arm II, Genotype A1

Patients receive docetaxel and vinorelbine ditartrate.

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

Given intravenously

vinorelbine tartrate

Intervention Type: DRUG

Given intravenously

Arm II, Genotype A2

Patients receive gemcitabine hydrochloride and vinorelbine ditartrate.

Group Type: EXPERIMENTAL

gemcitabine hydrochloride

Intervention Type: DRUG

Given intravenously

vinorelbine tartrate

Intervention Type: DRUG

Given intravenously

Arm II, Genotype B1

Patients receive docetaxel and carboplatin.

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

Given intravenously

docetaxel

Intervention Type: DRUG

Given intravenously

Arm II, Genotype B2

Patients receive gemcitabine hydrochloride and carboplatin.

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

Given intravenously

gemcitabine hydrochloride

Intervention Type: DRUG

Given intravenously

Interventions

carboplatin

Given intravenously

Intervention Type: DRUG

docetaxel

Given intravenously

Intervention Type: DRUG

gemcitabine hydrochloride

Given intravenously

Intervention Type: DRUG

vinorelbine tartrate

Given intravenously

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Principal Investigators

Byung Chul Cho

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Byung Chul Cho

Role: primary

82-2-222-822

Other Identifiers

YONSEI-4-2008-0132

Identifier Type: -

Identifier Source: secondary_id

SANOFI-AVENTIS-YONSEI-4-2008-0

Identifier Type: -

Identifier Source: secondary_id

CDR0000609880

Identifier Type: -

Identifier Source: org_study_id