First-Line Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
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ClinicalTrials.gov Identifier: NCT00736814 |
Recruitment Status
: Unknown
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted
: August 18, 2008
Last Update Posted
: February 24, 2011
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer | Drug: carboplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: vinorelbine tartrate | Phase 2 |
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.
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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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 117 participants |
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 |
Study Start Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
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
|
- Response rate (complete and partial responses)
- Disease control rate
- Response duration
- Progression-free survival
- Overall survival
- Toxicity

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

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
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 |
Principal Investigator: | Byung Chul Cho | Yonsei University |
ClinicalTrials.gov Identifier: | NCT00736814 History of Changes |
Other Study ID Numbers: |
CDR0000609880 YONSEI-4-2008-0132 SANOFI-AVENTIS-YONSEI-4-2008-0 |
First Posted: | August 18, 2008 Key Record Dates |
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 |