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)
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|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|
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.
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|