Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00021060
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Adenocarcinoma of the Lung
  • Bronchoalveolar Cell Lung Cancer
  • Large Cell Lung Cancer
  • Recurrent Non-small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • paclitaxel — DRUG
    Given IV
  • carboplatin — DRUG
    Given IV
  • bevacizumab — BIOLOGICAL
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells. This randomized phase II/III trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have advanced, metastatic, or recurrent non-small cell lung cance

Key Dates

First listed
Jan 27, 2003
Start date
Aug 31, 2002
Status verified
Feb 2013
Primary completion
Sep 30, 2006

Study Design

Enrollment
842 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (paclitaxel and carboplatin)
    Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1. Treatment in both arms repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (paclitaxel, carboplatin, and bevacizumab)
    Patients receive paclitaxel and carboplatin as in arm I followed by bevacizumab IV over 30-90 minutes on day 1. Treatment in both arms repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients in arm II with stable or responding disease continue to receive bevacizumab only. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Survival [ Time Frame: Up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Eastern Cooperative Oncology GroupBostonMassachusetts02215-

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Eastern Cooperative Oncology Group· Boston, MA

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