A Randomized Double-Blind Phase 3 Trial Comparing Vintafolide (Ec145) And Pegylated Liposomal Doxorubicin (Pld/Doxil®/Caelyx®) In Combination Versus Pld In Participants With Platinum-Resistant Ovarian Cancer
Posted Date: Sep 18, 2013
- Investigator: Eric Eisenhauer
- Type of Study: Drug
You are being asked to take part in a research study of an investigational drug called Vintafolide. Vintafolide was previously identified as EC145. Investigational means that the study drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA). This study compares the combination of PLD (Pegylated Liposomal Doxorubicin) and Vintafolide against the combination of PLD (Pegylated Liposomal Doxorubicin) and placebo. PLD is approved for sale in the United States by the FDA under the marketed name Doxil® and approved for sale by Health Authorities in European countries and marketed outside the United States as Caelyx® and is part of standard treatment for patients with ovarian cancer whose disease has progressed or recurred (came back) less than 6 months after prior platinum-based chemotherapy. The investigational drug, Vintafolide, will be given to some patients in combination with PLD/Doxil® / Caelyx®. Other patients will only receive PLD/Doxil® / Caelyx® and placebo. The purpose of this study is to test the effects of Vintafolide in combination with PLD/Doxil®/ Caelyx® in women with platinum-resistant ovarian cancer. We also want to test the safety of Vintafolide in combination with PLD/Doxil®/ Caelyx®. We would like to explain how we think the Vintafolide drug works: Vintafolide is called a “conjugate” drug, which means two substances are attached to each other. Vintafolide is a combination of folate, that is a B vitamin, and a type of anti-cancer chemotherapy drug known as a “vinca.” Your body is made up of many normal cells and a smaller number of cancerous cells. Both types of cells need the vitamin folate (vitamin B 9) to function. Some cancer cells demand more folate than their “normal” neighboring cells because of how fast they are growing. These cancer cells use a special method to capture the folate that is moving through your blood stream. They bypass the normal way folate enters the cells and use something called a folate receptor to capture (or grab) as much folate as they can out of the blood. In this way we think Vintafolide (folate and vinca) is grabbed by the cancer cells. When this happens the vinca is released into the cancer cell in hopes of killing it. Also, cells in certain types of cancer tend to have more of these folate receptors than others. Ovarian cancer cells are one of the types that generally have a higher number of folate receptors. Whether or not you will be able to participate in this study will depend upon whether your disease is “measurable” by CT scan at the beginning of the study. CT scans (procedures where a machine takes a picture of your whole body) are commonly used to monitor ovarian cancer. Doctors can look at CT scans taken at different times and tell how the cancer has changed since the last scan. If your tumors are large enough to be seen and measured clearly on the CT scan, then you have “measurable” disease. Your study doctor will tell you whether or not you have measurable disease. You can only participate in this study if your disease is considered “measureable”. Prior to starting treatment with PLD/Doxil®/ Caelyx® and Vintafolide or PLD/Doxil®/ Caelyx® and placebo, participants will have a nuclear medicine scan (which is like taking a picture) using an investigational imaging drug (a drug that shows up in a scan), called Technetium 99m Etarfolatide (99mTc-Etarfolatide, also known as 99mTc-EC20). 99mTc- Etarfolatide allows us to see the cells we think are more likely to “grab”Vintafolide. The 99mTc- Etarfolatide procedure has been performed in approximately 667 patients (with and without cancer) and has been found to be well tolerated. In order to minimize the chance of incorrectly influencing the results of the study, neither you nor your doctor will know the results of the 99mTc- Etarfolatide procedure.
You Are Being Asked To Take Part Because You Are 18 Years Of Age Or Older And Have “Platinum-Resistant” Ovarian Cancer. This Means Your Disease Progressed Or Recurred (Came Back) After Prior Platinum-Based Therapy.
Ec145, Gynecologic Oncology, Ovarian Cancer, Platinum Resistant, Vintafolide
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