In a Phase II clinical trial among women with recurrent ovarian cancer, the investigational targeted therapy AMG 386 produced promising response rates when used in combination with paclitaxel. These results were presented at the 35th European Society for Medical Oncology (ESMO) Congress.
Many women treated for ovarian cancer will eventually experience a recurrence of their cancer. Available treatments for recurrent ovarian cancer have limited effectiveness, and researchers continue to explore new approaches.
Targeted therapies are anticancer drugs that interfere with specific pathways involved in cancer cell growth or survival. Some targeted therapies block growth signals from reaching cancer cells; others reduce the blood supply to cancer cells; and still others stimulate the immune system to recognize and attack the cancer cell. Depending on the specific “target,” targeted therapies may slow cancer cell growth or increase cancer cell death.
AMG 386 is an investigational drug that inhibits the growth of new blood vessels by targeting two proteins: angiopoietin-1 and angiopoietin-2.
To evaluate AMG 386 in the treatment of recurrent ovarian cancer, researchers conducted a Phase II clinical trial among 161 women. Some study participants were treated with paclitaxel alone, and others were treated with paclitaxel plus AMG 386. Two different doses of AMG 386 were tested: 10 mg/kg or 3 mg/kg.
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- Overall survival was 22.5 months among patients who received the higher dose of AMG 386, 20.4 months among patients who received the lower dose of AMG 386, and 20.9 months among patients who were treated with paclitaxel alone.
- Survival without cancer progression was 7.3 months among patients who received the higher dose of AMG 386, 7.4 months among patients who received the lower dose of AMG 386, and 5.0 months among patients who were treated with paclitaxel alone.
- Response rate (as measured by CA-125 levels) was 71% among patients who received the higher dose of AMG 386, 58% among patients who received the lower dose of AMG 386, and 28% among patients who were treated with paclitaxel alone.
- Serious side effects that were more common in patients treated with AMG 386 included low blood potassium, peripheral neuropathy, loss of appetite, low white blood cell counts, and shortness of breath.
These results suggest that the addition of AMG 386 to paclitaxel may improve outcomes among women with recurrent ovarian cancer. Based on these and other results, a Phase III clinical trial is being started to further evaluate the role of AMG 386 in ovarian, primary peritoneal, and fallopian tube cancers.
Reference: Vergote I et al. A randomized, double-blind, placebo-controlled
phase II study of AMG 386 plus weekly paclitaxel in patients (pts) with advanced ovarian cancer. Presented at the 35th European Society for Medical Oncology (ESMO) Congress, Milan, Italy, October 8-12, 2010. Abstract 975PD.
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