A Phase II Trial of Irinotecan Liposome and Bevacizumab in Women with Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Ovarian cancer includes a group of malignant or cancerous conditions that originate in the ovaries, the fallopian tubes or the superficial layer of the abdominal wall, which is also known as the peritoneum. Although ovarian cancer is a relatively rare form of cancer, it causes more deaths than any other cancer from the female reproductive tract. Standard management includes the combination of surgery and chemotherapy. At the time of initial diagnosis, the standard chemotherapy regimen usually includes two drugs. The most important drug in this regimen is carboplatinum. Because of this, the initial chemotherapy regimen is described as being a "platinum-based regimen." Although the combination of surgery and platinum based chemotherapy is initially very effective in treating this cancer, the majority of women diagnosed with advanced ovarian cancer will experience a recurrence of their cancer. If the cancer returns within six months of the woman having completed the platinum based chemotherapy, the cancer is now described as being platinum resistant. Platinum resistant ovarian cancer is generally fatal and there are very limited treatment options for these patients. Therefore, the development of novel therapies for this deadly cancer is critically needed. Research in platinum-resistant ovarian cancer demonstrates that some of the chemotherapy agents used in this setting are more efficacious when combined with bevacizumab, which is a drug utilized in treating ovarian cancer. Bevacizumab works by slowing the growth of new blood vessels. While these combinations are tolerable, toxicity management remains challenging. The development of novel drug delivery systems, such as liposomal formulations, may help enhance therapeutic response while minimizing toxicity from the chemotherapy. Liposomal formulations consists of the drug being encased in a lipid layer to increase the amount of drug that gets delivered to the tumor. This may in turn improve the therapeutic response. Meanwhile, the protective lipid layer also minimizes normal; tissue exposure to the drug resulting in less toxicity. The current trial seeks to study the combination of irinotecan liposome and bevacizumab in women with recurrent, platinum resistant ovarian cancer. We predict that the liposomal encapsulation will enhance drug delivery and bioavailability, thereby improving efficacy and reducing toxicity.