Bevacizumab, Paclitaxel, Carboplatin, and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer

Stopped early · Phase 1

Conditions studied: Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Large Cell Lung Cancer, Stage II Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer

In brief

This phase I trial studies how well giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy to the chest works in treating patients with locally advanced non-small cell lung cancer. 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 tumor cells 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with paclitaxel, carboplatin, and radiation therapy may kill more tumor cells.

Key facts

Study ID

NCT00369551

Run by

National Cancer Institute (NCI)

People needed

36

Starts

2006-06-01

Last updated by the study team

2014-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed non-small cell lung carcinoma (NSCLC) meeting the following criteria:
• The following subtypes are eligible:
• Adenocarcinoma (including bronchoalveolar)
• Large cell carcinoma (including giant and clear cell carcinomas)
• Poorly differentiated carcinoma
• No squamous cell histology
• Unresectable stage II-III disease
• Tumor must not invade the trachea or major arterial or venous structures
• Measurable or evaluable disease
• Measurable disease defined as ? 1 lesion that can be accurately measured in ? 1 dimension as ? 20 mm with conventional techniques or as ? 10 mm with spiral CT scan
• No evidence of CNS disease, including primary brain tumor or brain metastases
• ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%
• Life expectancy > 6 months
• Granulocyte count ? 1,500/mm³
• Platelet count ? 100,000/mm³
• Bilirubin < 1.25 times upper limit of normal (ULN)
• AST < 2.5 times ULN
• Creatinine normalOR creatinine clearance ? 60 mL/min
• FEV_1 ? 1.0 liters
• 24-hour urine protein < 1,000 mg (for patients with urine protein:creatinine ratio [by urine analysis] > 1.0)
• No hemoptysis within the past 12 months (defined as bright red blood in sputum of > 1 teaspoon)
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• No history of allergic reactions attributed to carboplatin or taxane
• No serious or nonhealing wound, ulcer, or bone fracture
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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