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

Sponsor
Yonsei University
Study ID
NCT00736814
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • carboplatin — DRUG
    Given intravenously
  • docetaxel — DRUG
    Given intravenously
  • gemcitabine hydrochloride — DRUG
    Given intravenously
  • vinorelbine tartrate — DRUG
    Given intravenously

Study Details

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.

Key Dates

Start date
Jun 30, 2008
Status verified
Aug 2009

Study Design

Enrollment
117 participants (estimated)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I
    Patients receive standard chemotherapy of docetaxel and carboplatin.
  • Experimental: Arm II, Genotype A1
    Patients receive docetaxel and vinorelbine ditartrate.
  • Experimental: Arm II, Genotype A2
    Patients receive gemcitabine hydrochloride and vinorelbine ditartrate.
  • Experimental: Arm II, Genotype B1
    Patients receive docetaxel and carboplatin.
  • Experimental: Arm II, Genotype B2
    Patients receive gemcitabine hydrochloride and carboplatin.

Primary Outcome Measure

Response rate (complete and partial responses)

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