Radiation Therapy, Bevacizumab, Paclitaxel, and Carboplatin in Treating Patients With Unresectable Stage IIIB or Stage IV Non-Small Cell Lung Cancer at High Risk for Hemoptysis Caused by Bevacizumab

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00387374
Phase
PHASE2
Status
Completed

Conditions

  • Adenosquamous Cell Lung Cancer
  • Drug/Agent Toxicity by Tissue/Organ
  • Hemoptysis
  • Squamous 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

  • bevacizumab — BIOLOGICAL
    Given IV
  • paclitaxel — DRUG
    Given IV
  • carboplatin — DRUG
    Given IV
  • radiation therapy — RADIATION
    Undergo radiotherapy

Study Details

This phase II trial is studying the side effects and how well giving radiation therapy together with bevacizumab, paclitaxel, and carboplatin works in treating patients with unresectable stage IIIB or stage IV non-small cell lung cancer at high risk for hemoptysis caused by bevacizumab. Radiation therapy uses high-energy x-rays to kill tumor cells. It may also prevent hemoptysis caused by bevacizumab. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with bevacizumab and chemotherapy may kill more tumor cells

Key Dates

First listed
Oct 13, 2006
Start date
Oct 31, 2006
Status verified
Jan 2013
Primary completion
Jun 30, 2007

Study Design

Enrollment
72 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum I (radiotherapy, bevacizumab, chemotherapy)
    Patients undergo prophylactic radiotherapy on days 1-5 and 8-12. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 15. Patients also receive paclitaxel IV over 3 hours or carboplatin IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 36 (course 2).
  • Experimental: Stratum II (radiotherapy, chemotherapy, bevacizumab)
    Patients undergo prophylactic radiotherapy and receive paclitaxel and carboplatin as in stratum I. Patients also receive bevacizumab IV over 30-90 minutes on day 15 (course 1). In both strata, treatment with paclitaxel, carboplatin, and bevacizumab repeats every 21 days for 5-6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease may continue to receive single-agent bevacizumab every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Safety of treatment as measured by the incidence of grade 3-5 hemoptysis, as assessed by NCI CTCAE version 3.0 [ Time Frame: Up to 12 months after completion of treatment ]

Related Studies