In a phase II clinical trial of patients with stage IIIB or stage IV non-small cell lung cancer (NSCLC), the addition of rhAngiostatin (a drug that inhibits the formation of new blood vessels) to a standard chemotherapy regimen was feasible and resulted in reduced or stable disease in more than half the patients treated. These results were published in the Annals of Oncology.

Lung cancer remains the leading cause of cancer deaths in the U.S. and Europe. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 75%-80% of all lung cancers.

Stage IIIB NSCLC has already spread to more than one location in the chest, but cannot be detected outside the chest cavity with currently available diagnostic tests. Unfortunately, most of these patients have undetectable spread of cancer outside the chest. This undetectable cancer is the cause of relapse or recurrence of cancer in the majority of patients.

Stage IV non-small cell lung cancer (NSCLC) occurs when the disease has spread, or metastasized, and can be detected at different sites in the body, which may include the liver, brain, or other organs.

Because survival with stage IIIB and stage IV NSCLC is generally poor, researchers are focused on developing new therapeutic approaches. One approach being explored involves blocking the formation of new blood vessels. Cancer cells require food, oxygen, and growth proteins in order to grow and spread. These essential nutrients are transported to the cancer cells by blood vessels. The process of creating new blood vessels is called angiogenesis, and drugs that suppress angiogenesis may slow tumor growth.

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Recombinant human angiostatin (rhAngiostatin) is an investigational drug that inhibits the formation of new blood vessels. In order to explore the use of rhAngiostatin in combination with a standard chemotherapy regimen, researchers in Indiana conducted a phase II clinical trial among 24 patients with NSCLC. Patients were treated with up to six cycles of the chemotherapy drugs carboplatin and paclitaxel given in combination with rhAngiostatin.

  • 39% of patients experienced a reduction in detectable cancer after treatment.
  • 39% of patients achieved stabilization of their cancer.
  • 22% of patients had cancer that worsened during treatment.
  • 46% of patients survived for at least one year.
  • Serious adverse effects of treatment included fatigue, low white blood cell counts, shortness of breath, vascular problems, and infection.

The researchers note that the response rate in this study was comparable to or higher than the response rate after chemotherapy alone. They conclude that “rhAngiostatin in combination with paclitaxel and carboplatin is feasible and results in a high disease control rate in patients with advanced NSCLC.” They go on, however, to note that “further development of the drug is uncertain at this time.”

**Reference:**Kurup A, Lin C-W, Murry DJ et al. Recombinant Human Angiostatin (rhAngiostatin) in Combination with Paclitaxel and Carboplatin in Patients with Advanced Non-Small-Cell Lung Cancer: a Phase II Study from Indiana University. Annals of Oncology. 2006;17:97-103.

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