A Phase II Study of Secondary Cytoreduction with and without HIPEC plus Postoperative Chemotherapy for Women with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Protocol
12-275
Full Title
A Phase II Randomized Study: Outcomes after Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed By Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Phase
II
Disease Status
Relapsed/Refractory
Purpose

The purpose of this study is to see if giving hyperthermic intraperitoneal chemotherapy (HIPEC) during surgery, followed by standard postoperative chemotherapy, is more effective than standard postoperative chemotherapy without HIPEC for women with recurrent ovarian, fallopian tube, or primary peritoneal cancer who are having a second surgery to remove cancerous tissue in the abdomen.

HIPEC involves giving heated carboplatin (a standard drug for these cancers) directly into the abdomen at the end of a patient’s surgery. It is believed that heating the carboplatin may make it better able to penetrate and kill cancer cells.

All patients will have the surgery followed by standard postoperative chemotherapy. Patients will be randomly assigned to receive HIPEC at the end of surgery or not. Researchers will compare the incidence of recurrence and side effects between the two groups.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a first recurrence of ovarian, fallopian tube, or primary peritoneal cancer that initially responded to platinum-based therapy and returned more than 6 and less than 30 months after completing that therapy.
  • Patients must be candidates for a second surgery to remove cancerous tissue in the abdomen.
  • The cancerous tissue remaining after the second surgery should be less than 5 mm in size.
  • Patients may not have had prior chemotherapy for recurrent disease, nor any previous radiation therapy to the pelvis.
  • This study is open to patients age 21 and older.

For more information about this study, please contact Dr. Dennis Chi at 212-639-5016.

Disease(s)
Ovarian Cancer
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