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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

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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: vinorelbine tartrate Phase 2

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Response rate (complete and partial responses)

Secondary Outcome Measures :
  1. Disease control rate
  2. Response duration
  3. Progression-free survival
  4. Overall survival
  5. Toxicity

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Principal Investigator: Byung Chul Cho Yonsei University
More Information
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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:
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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
Carboplatin
Docetaxel
Vinorelbine
 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