Back to resultsWCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer
Primary Purpose
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperthermic intraperitoneal chemotherapy with Carboplatin
Isotonic saline (perfusate)
Surgery
Carboplatin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian cancer, recurrent fallopian tube cancer, recurrent peritoneal carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients should have a histological diagnosis of primary ovarian, fallopian tube, or primary peritoneal carcinoma and have undergone chemotherapy according.
- Initial attempted cytoreductive surgery must have been performed by gynecologic oncologist with strict adherence to GOG surgical manual.
- End result of first surgery must have been optimal cytoreduction as defined as no residual tumor ≥ 1cm.
- Patients should have clinical evidence of first recurrence. Two fold elevations in CA125 or measurable tumor on CT scan constitute adequate evidence of recurrent disease.
- Patients with the following primary tumor epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, adenocarcinoma (non-specific) NOS, mixed epithelial carcinoma.
- Patients must have platin sensitive disease, defined as a recurrence occurring greater than 6 months from cessation of original treatment.
- Patients must have a performance status of 0, 1, 2.
- Patients must have adequate bone marrow function as defined by an absolute neutrophil count (ANC) ≥1500, platelet count ≥ 100,000, and a hemoglobin of greater than 10g/dl.
- Patients must have adequate renal function as defined by serum creatinine ≤ 1.5 mg/dl.
- Patients must have adequate hepatic function as defined by bilirubin ≤ 1.5 times normal levels, alkaline phosphatase and SGOT ≤ 3 times normal levels.
- Patients who have signed an Institutional Review Board (IRB) approved informed consent.
- Female patients 16-90 years of age.
- Patients must be deemed medically able to undergo a secondary surgical procedure.
Patient eligibility for systemic chemotherapy following HIPC:
- Patients must have successfully completed HIPC within 6 weeks of first prescribed intravenous carboplatin and taxane cycle.
- Patients must have a performance status of 0, 1, or 2.
- Patients must have adequate bone marrow function as defined as an ANC ≥ 1500, platelet count ≥ 100,000, and a hemoglobin of greater than 10g/dl.
- Patients must have adequate renal function as defined by serum creatinine ≤ 1.5 mg/dl.
- Patients must have adequate hepatic function as defined by bilirubin ≤ 1.5 times normal levels, alkaline phosphatase and SGOT ≤ 3 times normal levels.
- Patients who have signed an IRB approved informed consent.
Exclusion Criteria:
- Patients with known recurrent disease outside the abdominal cavity.
- Patients with low malignant tumor at primary diagnosis as determined by pathologic review.
- Patients with platin resistant disease as define as recurrence or progressive disease prior to 6 months from completion of primary therapy.
- Patients with any evidence of another malignancy within the last 5 years with the exception of non-melanoma skin cancer.
- Patients with evidence of concurrent septicemia, severe infection, renal failure, or acute hepatitis.
- Patients with history of grade 3 or greater gastrointestinal bleeding.
- Patients with a GOG performance score of 3 or 4.
- Patients deemed medically unable to tolerate the HIPC procedure by care giving physician.
- Patients with known allergy to platinum chemotherapy agents.
- Patients with equal to or greater than grade 2 neuropathy.
Sites / Locations
- Masonic Cancer Center, University of Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HIPC Treatment
Arm Description
Outcomes
Primary Outcome Measures
Clinical Response
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
We will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.
Secondary Outcome Measures
Quality of Life Measurements
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
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
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.
Full Information
NCT ID
NCT01144442
First Posted
May 26, 2010
Last Updated
July 10, 2019
Sponsor
Masonic Cancer Center, University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01144442
Brief Title
WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer
Official Title
WCC# 59: Pilot Study of Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
PI Request
Study Start Date
July 27, 2010 (Actual)
Primary Completion Date
September 25, 2013 (Actual)
Study Completion Date
May 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an open-label, pilot study in patients with a diagnosis of recurrent ovarian, fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive surgery following by adjuvant chemotherapy. It is expected that this first surgery was optimal - as defined as no residual tumor > or = 1 centimeter. Patient has clinical evidence of a first recurrence. The patient undergoes surgery and isotonic normal saline (perfusate) heated and administered into the abdomen, followed by hyperthermic intraperitoneal chemotherapy infusion (HIPC) administering carboplatin (chemotherapy). Six weeks after surgery patients will receive adjuvant chemotherapy with Paclitaxel and Carboplatin for 6 cycles.
Detailed Description
OBJECTIVES
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma
Keywords
recurrent ovarian cancer, recurrent fallopian tube cancer, recurrent peritoneal carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIPC Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hyperthermic intraperitoneal chemotherapy with Carboplatin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Isotonic saline (perfusate)
Other Intervention Name(s)
saline
Intervention Description
The HIPC infusion will be performed with a closed abdomen technique. The perfusate will be isotonic saline heated to 40-42° Celsius.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.
Primary Outcome Measure Information:
Title
Clinical Response
Description
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.
Time Frame
After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)
Title
Feasibility of HIPC in Recurrent Disease Setting
Description
We will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life Measurements
Description
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.
Time Frame
Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27
Title
Progression-free Survival
Description
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).
Time Frame
Up to 5 Years (intended)
Title
Overall Survival
Description
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.
Time Frame
Up to 5 Years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients should have a histological diagnosis of primary ovarian, fallopian tube, or primary peritoneal carcinoma and have undergone chemotherapy according.
Initial attempted cytoreductive surgery must have been performed by gynecologic oncologist with strict adherence to GOG surgical manual.
End result of first surgery must have been optimal cytoreduction as defined as no residual tumor ≥ 1cm.
Patients should have clinical evidence of first recurrence. Two fold elevations in CA125 or measurable tumor on CT scan constitute adequate evidence of recurrent disease.
Patients with the following primary tumor epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, adenocarcinoma (non-specific) NOS, mixed epithelial carcinoma.
Patients must have platin sensitive disease, defined as a recurrence occurring greater than 6 months from cessation of original treatment.
Patients must have a performance status of 0, 1, 2.
Patients must have adequate bone marrow function as defined by an absolute neutrophil count (ANC) ≥1500, platelet count ≥ 100,000, and a hemoglobin of greater than 10g/dl.
Patients must have adequate renal function as defined by serum creatinine ≤ 1.5 mg/dl.
Patients must have adequate hepatic function as defined by bilirubin ≤ 1.5 times normal levels, alkaline phosphatase and SGOT ≤ 3 times normal levels.
Patients who have signed an Institutional Review Board (IRB) approved informed consent.
Female patients 16-90 years of age.
Patients must be deemed medically able to undergo a secondary surgical procedure.
Patient eligibility for systemic chemotherapy following HIPC:
Patients must have successfully completed HIPC within 6 weeks of first prescribed intravenous carboplatin and taxane cycle.
Patients must have a performance status of 0, 1, or 2.
Patients must have adequate bone marrow function as defined as an ANC ≥ 1500, platelet count ≥ 100,000, and a hemoglobin of greater than 10g/dl.
Patients must have adequate renal function as defined by serum creatinine ≤ 1.5 mg/dl.
Patients must have adequate hepatic function as defined by bilirubin ≤ 1.5 times normal levels, alkaline phosphatase and SGOT ≤ 3 times normal levels.
Patients who have signed an IRB approved informed consent.
Exclusion Criteria:
Patients with known recurrent disease outside the abdominal cavity.
Patients with low malignant tumor at primary diagnosis as determined by pathologic review.
Patients with platin resistant disease as define as recurrence or progressive disease prior to 6 months from completion of primary therapy.
Patients with any evidence of another malignancy within the last 5 years with the exception of non-melanoma skin cancer.
Patients with evidence of concurrent septicemia, severe infection, renal failure, or acute hepatitis.
Patients with history of grade 3 or greater gastrointestinal bleeding.
Patients with a GOG performance score of 3 or 4.
Patients deemed medically unable to tolerate the HIPC procedure by care giving physician.
Patients with known allergy to platinum chemotherapy agents.
Patients with equal to or greater than grade 2 neuropathy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Argenta, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer
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