WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT01144442|
Recruitment Status : Completed
First Posted : June 15, 2010
Results First Posted : September 5, 2013
Last Update Posted : March 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Peritoneal Carcinoma||Drug: Hyperthermic intraperitoneal chemotherapy with Carboplatin Other: Isotonic saline (perfusate) Procedure: Surgery Drug: Carboplatin Drug: Paclitaxel||Not Applicable|
The primary objectives are
- to determine the clinical response of hyperthermic intraperitoneal chemotherapy (HIPC) in patients at the time of first clinical recurrence of ovarian, fallopian tube, or primary peritoneal carcinoma
- to determine the feasibility of delivering HIPC in a recurrent setting.
Secondary objectives are
- to determine disease free survival (DFS) and overall survival (OS),
- to determine treatment related changes in quality of life (QOL)
- to monitor the toxicities and complications associated with HIPC.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||WCC# 59: Pilot Study of Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2013|
U.S. FDA Resources
Experimental: HIPC Treatment
Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
Drug: Hyperthermic intraperitoneal chemotherapy with Carboplatin
Carboplatin at a dose of 1000mg/m^2 will be added to the perfusate once circulating levels reach 1000-1500cc/minute. The circulation of the chemotherapy impregnated perfusate will be performed for 90 minutes.Other: Isotonic saline (perfusate)
The HIPC infusion will be performed with a closed abdomen technique. The perfusate will be isotonic saline heated to 40-42° Celsius.
Other Name: salineProcedure: Surgery
The abdominal incision will be performed in a vertical fashion extending from the supra-pubic region to around the umbilicus.
If cytoreductive surgery is required, it will be performed at this time and proceed in standard approach.
The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.Drug: Paclitaxel
The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.
Other Name: Taxol
- Clinical Response [ Time Frame: After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27) ]We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.
- Feasibility of HIPC in Recurrent Disease Setting [ Time Frame: 6 months ]We will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.
- Quality of Life Measurements [ Time Frame: Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27 ]The quality of life measurements (version 4 of the FACT-O questionnaire) will be summed over each subscale and overall and comparisons will be made using t-tests at distinct visits.
- Progression-free Survival [ Time Frame: Up to 5 Years ]Disease progression will be defined as time from surgery to first of either an increase in CA125 from post-treatment value (to a value greater than 100 or doubling of nadir CA125 levels) or new/increasing measurable disease by CT scan as defined by RECIST criteria, (secondary recurrence) or censored at date of last contact for patients still alive and who have no progressed or recurred (from date of surgery to disease progression).
- Overall Survival [ Time Frame: Up to 5 Years ]Overall survival will be defined as time from date of surgery to date of death or censored at the date of last documented contact for patients still alive.
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): NCT01144442
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Peter Argenta, MD||Masonic Cancer Center, University of Minnesota|