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Cisplatin

Orange

PLATINOL®-AQ (cisplatin injection) is a clear, colorless, sterile aqueous solution, each mL containing 1 mg cisplatin and 9 mg Sodium Chloride, USP. HCl and/or Sodium Hydroxide is added to adjust pH of the solution. The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula PtCl2H6N2, and a molecular weight of 300.1. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207°C.

Whole abdominal radiotherapy will be delivered with an open-field anterior-posterior/posterior-anterior technique. Radiation will be administered in a dose escalating fashion to determine toxicity. The maximal dose of radiation will be defined as a mean midplane dose to the abdomen of 3,000 Gy through parallel-opposed single ports with a 1-cm margin that will cover the entire abdomen including the diaphragm.

Whole Abdomen Radiotherapy

Andrew P. Soisson

The proposed study is a prospective cohort study incorporating patients with first recurrence ovarian or primary peritoneal cancer who will receive intraperitoneal chemotherapy in conjunction with whole abdomen radiation. The primary end point of this investigator initiated research study is to determine the toxicity associated with whole abdomen radiation in combination with intraperitoneal chemotherapy.

Primary Objective:

* 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.

Secondary Objective:

* Quality of Life assessment.

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 cancer.

Screening Procedures:

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 radiation treatments.
* 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.

Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity

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

University of Utah

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity	NCT00942838	Recurrent Ovari...	Cisplatin Whole Abdomen R...	18 Years -	University of Utah
Whole Abdomen Radiation in Conjunction With Intraperitoneal Chemotherapy for the Treatment of Small Volume Recurrent Ovarian Carcinoma Limited to the Peritoneal Cavity	NCT00942838	Recurrent Ovari...	Cisplatin Whole Abdomen R...	18 Years -	University of Utah

Spots Global Cancer Trial Database for whole abdomen radiotherapy