Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity: A Phase I Trial
DESIGN: This is an open label, single arm, dose finding study.
STUDY PROCEDURES: Patients will receive chemotherapy and radiation for four weeks, and we
will check for any problems from the treatment for 3 months. We would like to collect
information from the patients regular doctor for 1 year after this treatment.
Pre-screening If patients decide to participate in this study the doctor will evaluate if
they have met all the criteria to be eligible. To participate the cancer cannot have spread
outside the abdomen and patients must have had only one type of chemotherapy for their
cancer. If there any of their previous scans or blood tests show that the cancer has spread
outside the abdominal cavity, patients will not be able to participate in this study.
Patients will also not be able to participate in this study if it is determined that their
cancer has come back less than six months after they completed their first treatment of
chemotherapy. If these criteria are met, the standard next step for treatment is to have a
second surgery to remove all or most of the cancer from the abdominal cavity. This will
involve a similar surgery to what patients had when their cancer was first diagnosed. During
this surgery we will place a special catheter or tube within the abdominal cavity so that we
can administer chemotherapy into the abdomen directly and deliver it to the remaining
The following screening tests, exams and procedures will be done:
- Recording of medical history, physical exam (including vital signs, height & weight
assessment, pelvic examination)
- Blood tests (approximately 2-3 teaspoons will be drawn)
- Urine tests
- Quality of life questionnaire
- If patients have a history of hearing loss, they will have a hearing test because
cisplatin can affect hearing.
Chemotherapy and Radiation Treatment:
- Chemotherapy (Cisplatin) will be given to after recovery from surgery. It will be given
once per week at the same time as patients begin receiving the radiation treatment for
the first 4 weeks. The chemotherapy will be given through the catheter (tube) that was
placed under the skin during surgery and will not be visible. Patients will receive
medication prior to the chemotherapy to prevent nausea, vomiting, and possible allergic
reaction. Each infusion of chemotherapy will take approximately 60 minutes. After
patients receive the drug we will ask to change positions to ensure that the drug comes
in contact with all parts of the abdomen.
- Radiation therapy will be administered for four weeks. Radiation treatments will be
given every day (Monday through Friday) for approximately four weeks.
- Weekly blood tests will be taken before patients receive the chemotherapy
(approximately 2-3 teaspoons) to monitor the effects of the drug on the body.
- The study doctor will evaluate patients weekly with a physical exam and review their
blood tests for any side effects they might be having from the chemotherapy or
- Complete a quality of life questionnaire each week.
At the end of treatment (beginning of week 5) AND approximately 90 days after the completion
of treatment patients will have a physical exam, blood tests evaluation of the side effects,
and will complete a quality of life questionnaire.
At the end of treatment, patients will likely undergo additional standard chemotherapy
treatment. We would like to collect and review the information about their progress and
care for 12 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose (MTD) of whole abdomen radiation in conjunction with intraperitoneal cisplatin chemotherapy in the treatment of women with small volume (< 1 cm) recurrent ovarian cancer confined to the abdominal peritoneal cavity
2 years after study start
Andrew P. Soisson
Huntsman Cancer Institute
United States: Institutional Review Board
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|