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 because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00736814
First received: August 15, 2008
Last updated: February 23, 2011
Last verified: August 2009

August 15, 2008
February 23, 2011
June 2008
Not Provided
Response rate (complete and partial responses) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00736814 on ClinicalTrials.gov Archive Site
  • Disease control rate [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
First-Line Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Genotype-driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy

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.

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.
Interventional
Phase 2
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: carboplatin
    Given intravenously
  • Drug: docetaxel
    Given intravenously
  • Drug: gemcitabine hydrochloride
    Given intravenously
  • Drug: vinorelbine tartrate
    Given intravenously
  • Active Comparator: Arm I
    Patients receive standard chemotherapy of docetaxel and carboplatin.
    Interventions:
    • Drug: carboplatin
    • Drug: docetaxel
  • Experimental: Arm II, Genotype A1
    Patients receive docetaxel and vinorelbine ditartrate.
    Interventions:
    • Drug: docetaxel
    • Drug: vinorelbine tartrate
  • Experimental: Arm II, Genotype A2
    Patients receive gemcitabine hydrochloride and vinorelbine ditartrate.
    Interventions:
    • Drug: gemcitabine hydrochloride
    • Drug: vinorelbine tartrate
  • Experimental: Arm II, Genotype B1
    Patients receive docetaxel and carboplatin.
    Interventions:
    • Drug: carboplatin
    • Drug: docetaxel
  • Experimental: Arm II, Genotype B2
    Patients receive gemcitabine hydrochloride and carboplatin.
    Interventions:
    • Drug: carboplatin
    • Drug: gemcitabine hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
117
Not Provided
Not Provided

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
Both
18 Years and older
No
Korea, Republic of
 
NCT00736814
CDR0000609880, YONSEI-4-2008-0132, SANOFI-AVENTIS-YONSEI-4-2008-0
Not Provided
Not Provided
Yonsei University
Not Provided
Principal Investigator: Byung Chul Cho Yonsei University
National Cancer Institute (NCI)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP