A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined With Either Trastuzumab and Hyaluronidase-Oysk (HERCEPTIN HYLECTA) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma
Volunteers
Health Professionals
What is the purpose of this trial?
This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.
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Principal Investigator
Sub-Investigators
- Agatha Hecht
- Alison Johnson
- Anca Bulgaru, MD
- Andrea Brennan
- Beverly Drucker, MD, PhD
- Blair Colette McNamara, MD
- Clarice Grens
- D. Barry Boyd, MD, MS
- Elan Gorshein, DO, JD, MPH
- Elena Ratner, MD, MBA
- Emily Kopas, APRN, OCN
- Gary Altwerger, MD
- Gloria Huang, MD, FACOG
- James Vredenburgh, MD
- Jamie Malette
- Jose Morales-Marin
- Justin Persico, MD
- Kathleen Fenn, MD
- Kayla Martello
- Kert Sabbath, MD, FACP
- Kristen Hoxie
- Larisa Fleysher
- Laura Sabourin
- Madeline Santiago
- Martha Diaz
- Masoud Azodi, MD
- Megin Iaccarino
- Michael Burke
- Michael Grant, MD
- Mitchell Clark, MD, MPH
- Nesrine Khoury
- Osarugue Otasowie
- Pawan Karanam, MD
- Peter Dottino, MD, FACOG
- Renee Moye
- Stephen Lattanzi, MD
- Vidya Kesavan
- Wajih Kidwai, MD, FACP
- Zia Rahman, MD
- Last Updated12/04/2024
- Study HIC#2000033613