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 (HIPEC)
|ClinicalTrials.gov Identifier: NCT01659554|
Recruitment Status : Terminated (Principal Investigator left institution)
First Posted : August 8, 2012
Results First Posted : March 3, 2015
Last Update Posted : March 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Ovarian Cancer Fallopian Tube Cancer||Drug: Cisplatin Drug: Doxorubicin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Peritoneal and Fallopian Tube Cancers|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
U.S. FDA Resources
Experimental: Out-Patient Intraperitoneal Chemotherapy
Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle.
Cisplatin (75 mg/m2) prepared in 2L normal saline.
Other Names:Drug: Doxorubicin
Doxorubicin (25 mg flat dose) prepared in 500 ml dialysis fluid (glucose or icodextrin-based).
- 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).
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659554
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Sharyn Lewin, MD||Columbia University|