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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00736814

First Posted: August 18, 2008

Last Update Posted: February 24, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

National Cancer Institute (NCI)

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: vinorelbine tartrate	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Genotype-driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate (complete and partial responses)

Secondary Outcome Measures:

Disease control rate
Response duration
Progression-free survival
Overall survival
Toxicity


Estimated Enrollment:	117
Study Start Date:	June 2008

Arms	Assigned Interventions
Active Comparator: Arm I Patients receive standard chemotherapy of docetaxel and carboplatin.	Drug: carboplatin Given intravenously Drug: docetaxel Given intravenously
Experimental: Arm II, Genotype A1 Patients receive docetaxel and vinorelbine ditartrate.	Drug: docetaxel Given intravenously Drug: vinorelbine tartrate Given intravenously
Experimental: Arm II, Genotype A2 Patients receive gemcitabine hydrochloride and vinorelbine ditartrate.	Drug: gemcitabine hydrochloride Given intravenously Drug: vinorelbine tartrate Given intravenously
Experimental: Arm II, Genotype B1 Patients receive docetaxel and carboplatin.	Drug: carboplatin Given intravenously Drug: docetaxel Given intravenously
Experimental: Arm II, Genotype B2 Patients receive gemcitabine hydrochloride and carboplatin.	Drug: carboplatin Given intravenously Drug: gemcitabine hydrochloride Given intravenously

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736814

Locations


Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center	Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Byung Chul Cho 82-2-222-822

Sponsors and Collaborators

Yonsei University

Investigators


Principal Investigator:	Byung Chul Cho	Yonsei University

More Information


ClinicalTrials.gov Identifier:	NCT00736814 History of Changes
Other Study ID Numbers:	CDR0000609880 YONSEI-4-2008-0132 SANOFI-AVENTIS-YONSEI-4-2008-0
First Submitted:	August 15, 2008
First Posted:	August 18, 2008
Last Update Posted:	February 24, 2011
Last Verified:	August 2009

Keywords provided by National Cancer Institute (NCI):


stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Docetaxel Vinorelbine Carboplatin	Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic

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