Birinapant for Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer

Summary

Background: \- Birinapant is an experimental cancer treatment drug. It removes certain proteins in cells, which helps to kill the cells. The drug is more likely to cause the death of cancer cells than normal cells because cancer cells have more of these proteins. Studies suggest that it can help treat ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Researchers want to see how well Birinapant works against the three types of cancer. Objectives: \- To test the effectiveness of Birinapant for ovarian, primary peritoneal, or fallopian tube cancer. Eligibility: \- Women at least 18 years of age who have ovarian, primary peritoneal, or fallopian tube cancer that has not responded to standard treatment. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. Tumor tissue samples may be collected before treatment. Imaging studies will also be performed. * Participants will have an infusion of Birinapant once per week for 3 weeks in a row, followed by a break for a week on the fourth week. This 4-week schedule is one cycle of treatment. * Treatment will be monitored with frequent blood tests and imaging studies. * Another optional tumor biopsy will be collected 6 weeks after the start of treatment. * Treatment will continue as long as the cancer does not grow and the side effects are not severe.

Timeline

Start

2012-08-15

Primary completion

2013-12-09

Completion

2014-04-30

Publications

• Background Kaye SB. Management of platinum-sensitive relapsed ovarian cancer, with particular reference to the International Collaboration in Ovarian Neoplasm-4/Arbeitsgemeinschaft Gynakologische Onkologie Ovarian Cancer-2.2 trial. Int J Gynecol Cancer. 2005 May-Jun;15 Suppl 1:31-5. doi: 10.1111/j.1525-1438.2005.15354.x.
• Background Rose PG, Tian C, Bookman MA. Assessment of tumor response as a surrogate endpoint of survival in recurrent/platinum-resistant ovarian carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2010 May;117(2):324-9. doi: 10.1016/j.ygyno.2010.01.040. Epub 2010 Feb 24.
• Background Gordon AN, Granai CO, Rose PG, Hainsworth J, Lopez A, Weissman C, Rosales R, Sharpington T. Phase II study of liposomal doxorubicin in platinum- and paclitaxel-refractory epithelial ovarian cancer. J Clin Oncol. 2000 Sep;18(17):3093-100. doi: 10.1200/JCO.2000.18.17.3093.

Drugs

Indications