A randomized, double-blind, placebo-controlled phase II study of VTX-2337 (IND#78,416) in combination with pegylated lipsomal doxorubicin (PLD) in patients with recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Epithelial ovarian, fallopian tube, and primary peritoneal cancers carry the highest fatality to case ratio for all gynecologic malignancies diagnosed within the United States. Standard treatment for this type of cancer may consist of a variety of chemotherapy drugs including: Paclitaxel, Topotecan and Pegylated Liposomal Doxorubicin (PLD).
PLD is a special formulation of the drug Doxorubicin, in which the Doxorubicin is wrapped in a fat bubble. This is done to increase the amount of drug that reaches the tumor while also decreasing side effects.
VTX-2337 is an experimental drug that stimulates you immune system and may help the patient's body to kill cancer cells. This drug is given through a subcutaneous injection. (A shot under the skin.)
The purpose of this study is to compare PLD to PLD in combination with VTX-2337 to see if it helps to stop a patient's cancer cells from growing and eventually shrink. It is hoped that by shrinking the patient's cancer cells this might help to increase the patient's life expectancy.
In addition to the treatment part of this study researchers will also collect blood and tumor tissue sampled from participants to further study this disease. Researchers will also collect a sample of your DNA from participant's blood in order to determine if they possess a gene responsible for the production of a receptor for VTX-2337. This gene has a natural variation that may possibly result in different responses to the study drug in different patients.
You may qualify for this study if you:
- Patients Must Have:
- Female aged 18 or older
- Persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- Measurable disease
- Received treatment with a platinum-based chemotherapeutic regimen for management of primary disease
- Platinum resistant disease
- Adequate organ and blood functions as evidenced by laboratory studies
- Be free of active infection requiring antibiotics
- Cessation of hormonal, chemotherapy, radiation therapy and biologic/targeted therapy prior to study treatment.
Janet L. Osborne, M.D.
Vickie Yates, RN
Clinical Research Nurse Coordinator