A Phase II Trial of Intraperitoneal Paclitaxel and Carboplatin Therapy in the Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin
Patients will have an intraperitoneal port placed at the time of their initial surgery or at
a second procedure prior to cycle 2 of chemotherapy.
Patients will receive a total of 6 cycles of therapy as an outpatient. They will have 1
cycle of paclitaxel/carboplatin intravenously followed by 5 cycles of paclitaxel/carboplatin
intraperitoneally. Chemotherapy treatment is given on days 1, 8, and 15 of each cycle.
Each cycle is 21 days long.
To help reduce the chance of an allergic reaction, patients will also take decadron tablets
orally before paclitaxel administration.
About 1 liter of standard salt solution will be injected through a catheter into the
abdominal cavity with each treatment to help distribute the drugs throughout the abdominal
"Second-look" surgery (laparoscopy or laparotomy) will be performed 3-8 weeks after the last
chemotherapy course (cycle 6) if the patient is in complete clinical remission. This
surgery is done to see how effective the chemotherapy was.
Tests and procedures will be done throughout the treatment to see how the cancer is
responding and to monitor for safety purposes. These tests and procedures include routine
history and physical exam, neurological exam, and routine blood tests. As part of this
study we will also be checking the amount of paclitaxel and carboplatin in the blood.
Participation in this study will last approximately 6 months as long as the treatment is
well tolerated, there are no serious side effects and the disease has not progressed.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To investigate the safety and tolerability of carboplatin and paclitaxel administered intraperitoneally
Carolyn Krasner, MD
Massachusetts General Hospital
United States: Institutional Review Board