Clinical Trial: A Phase II Combined Modality Protocol of Debulking Surgery With HIPEC Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal & Fallopian Tube Cancers

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Combined Modality Protocol of Debulking Surgery With Heated Intraoperative Chemotherapy (HIPEC) Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peri

Brief Summary: The primary objective of this study is to investigate the feasibility, tolerability and safety of surgical debulking and resection with heated intraoperative chemotherapy (HIPEC) followed by repeated intraperitoneal chemotherapy for treatment of recurrent ovarian, primary peritoneal, and fallopian tube carcinomas.

Detailed Summary: This is a phase II , open label, single center study of surgery followed by heated intraoperative cisplatin in patients with recurrent ovarian, primary peritoneal or fallopian tube cancers. Approximately twenty patients will receive surgery and intraoperative (hyperthermic) cisplatin followed by four consecutive courses of outpatient intraperitoneal cisplatin and doxorubicin given on days 1 and 8 during a 3 week cycle.
Sponsor: Columbia University

Current Primary Outcome:

• Adverse Event Rate and/or Laboratory Changes [ Time Frame: 5 years ]
  The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.
• Toxicity Rating Based on NCI Common Toxicity Criteria [ Time Frame: Up to 5 years ]
  Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Time to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria) [ Time Frame: Up to 5 years (survival) ]
  Efficacy of surgical resection with HIPEC combined with repeated intraperitoneal chemotherapy: The end point will be the objective response rate and progression-free survival as well as the overall survival, if feasible. We will analyze the time to serum Ca 125 nadir and/or CT response based on Recist criteria.
• Kaplan-Meier Curves for Patient Overall Survival [ Time Frame: Up to 5 years, survival ]
  Kaplan-Meier analysis will be done using PROC LIFETEST in Statistical Application Software (SAS).

Original Secondary Outcome: Same as current

Information By: Columbia University

Dates:
Date Received: July 10, 2012
Date Started: March 2012
Date Completion:
Last Updated: January 30, 2017
Last Verified: January 2017