Overview

This trial is active, not recruiting.

Conditions ovarian cancer, fallopian tube cancer, peritoneal carcinoma
Treatments hyperthermic intraperitoneal chemotherapy with carboplatin, isotonic saline (perfusate), surgery, carboplatin, paclitaxel
Sponsor Masonic Cancer Center, University of Minnesota
Start date August 2010
End date September 2012
Trial size 10 participants
Trial identifier NCT01144442, 1003M78874, 2009LS114, WCC# 59

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
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.
isotonic saline (perfusate) saline
The HIPC infusion will be performed with a closed abdomen technique. The perfusate will be isotonic saline heated to 40-42° Celsius.
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.
carboplatin
The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.
paclitaxel Taxol
The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.

Primary Outcomes

Measure
Clinical Response
time frame: After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)
Feasibility of HIPC in Recurrent Disease Setting
time frame: 6 months

Secondary Outcomes

Measure
Quality of Life Measurements
time frame: Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27
Progression-free Survival
time frame: Up to 5 Years
Overall Survival
time frame: Up to 5 Years

Eligibility Criteria

Female participants from 16 years up to 90 years old.

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.

Additional Information

Official title WCC# 59: Pilot Study of Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence
Principal investigator Peter Argenta, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota.