WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer

NCT ID: NCT01144442

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-27
• Study Completion Date: 2015-05-01

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIPC Treatment

Group Type: EXPERIMENTAL

Hyperthermic intraperitoneal chemotherapy with Carboplatin

Intervention Type: DRUG

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)

Intervention Type: OTHER

The HIPC infusion will be performed with a closed abdomen technique. The perfusate will be isotonic saline heated to 40-42° Celsius.

Surgery

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.

Paclitaxel

Intervention Type: DRUG

The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

Carboplatin

The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.

Intervention Type: DRUG

Paclitaxel

The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.

Intervention Type: DRUG

Other Intervention Names

saline; Taxol

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Argenta, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

WCC# 59

Identifier Type: OTHER

Identifier Source: secondary_id

1003M78874

Identifier Type: OTHER

Identifier Source: secondary_id

2009LS114

Identifier Type: -

Identifier Source: org_study_id