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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief Summary:

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.

Detailed Summary:

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
  Sponsor: University of Utah
  

  Current Primary Outcome: 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 [ Time Frame: 2 years after study start ]
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome: Quality of Life assessment [ Time Frame: 2 years after study start ]
  
  

  Original Secondary Outcome: Same as current
  
  Information By: University of Utah
  

  Dates:
  Date Received: July 17, 2009
  Date Started: July 2009
  Date Completion:
  Last Updated: July 23, 2013
  Last Verified: July 2013